>> well, good morning, everyone. thank you so much for beinghere, i'm janine clayton, director of office of researchon women's health and i'm really pleased to welcome you here tothe national women's health week panel event. for this year, the office ofresearch on women's health hosts an event every year duringnational women's health week and our event is meet the faces ofclinical research beyond inclusion.
thank you so much for beinghere. just like mother's day is justone day in the year that we honor our mothers, women'shealth week is just one week in the year that we highlightwomen's health specifically, but we do it every day, 365 days ayear, sometimes autoweekend, very often at night and everyday in terms of women's health. i'm thrilled to welcome you totoday's gathering which is a conversation. you see from our set up, it's alittle different from a typical
lipsett auditorium event butthis is a conversation and i really would like you to be partof that conversation. i challenge you to share yourthoughts, ask your questions and don't hold back interestingcomments you want to make, we want to hear from you. we have phenomenal specialguests today that include women who are clinical researchvolunteers and health professionals that support themand many other people who partic paint in clinical research.
together these people give theirtime and talent and effort and energy and because of all ofthat, they create new knowledge that advances all of our health. today we're celebrating the manyfaces of clinical research and women of different backgroundswho are confronting different health issues, each of these isindividual and when all of us are a patient, we all have thesame feelings about where to go. and we are also looking at usingunique and personal strategies to help themselves ourselves andeveryone.
so thank you everyone who joinsu today. this year 2015 is also a reallyspecial year at nih, the office of research on women's healths&p 25 years old this year. so we should clap for that. at 25, you still think you cando everything and change the world and we still think we cando everything and change the world. i's been also more than 20years since it is federal law required that women be includedin nih supported research and
today women are roughly 50% ofall nih supported clinical research. that is great news. however in 2015 we are atanother turning point. one year ago today, literallyone year ago today, nih director francis collins will take actionto insure that nih researchers count for sex and the biologicaland preclinical research and we took this very important stepbecause unfortunately for the most part those preclinicalstudies before we go into the clinic have it done primarily inmales.
why does that matter? because males and females aredifferent right down to our dna, while men and women get the samediseases or those that only effect men or only effect women,the prevalence is different, like autoimmune diseases or likecancer, some cancers like lung cancer which has a differentprofile in men, symptoms who are in men, women who may have aheart attack may not have crushing chest pains they maynot feel like an elephant is sitting on their chest and weneed understand why that is.
we learned in the last year thatmedications and specifically one medication sleep aid is half forwomen than for men, so we have a lot to learn and our differencesare important every day. so in 2015 we're working hard toput in place new policies for expanding the foundation ofclinical research to understand both female biology and malebiology. this information as it growswill inform our future clinical studies and will lead to betterhealth outcomes for women and men, boys and girls.
now another key point thathardly needs mentioning is that not all women are the same. look at this beautiful andvaried audience. we're not all the same. just like women are not, somesort ofotinate version of a man, children are not small adults,we need to consider all of the factors that drive our healthand effect our risker for illness and disease: race andethnicity, our jobs and recreational interest, where welive, our cultural influences
and behaviors. things within our control andthings not in our control. let me close by saying wecelebrate women and their health and recognize the spectrum ofissues that define us as individuals and also play a rolein our health. all of us here, researchvolunteers, scientists, government employees and friendsand family, and thank you to all of you who've come today arepartners in advancing health. thank you for all that you do.
[ applause ]now i'd like to introduce our key note speaker, friend,colleague and incredible women, dr. lauren wood who is visitingus today from the national cancer institute. if i could use one word thatdribbing lauren and she's sort of blushing, it would bepassionate, as you hear today, she is an energetic and caringdoctor who really enjoys working with her patients. she tests new cancer and hivtherapy and as i said she brings
a spark to everything she does,i know you will enjoy hearing her and the rest of today'svoices. lauren? [ applause ]>> so, i want to thank janine and the staff of orwh for theopportunity to just speak with you briefly and since the focusof this session was really to be about a conversation, and therewas not a requirement for slides but i was like, no, slides? ahh!
but i have 20 minutes and i onlyhave 12 slides for any of those of you who have ever seen mespeak normally, i'm like my colleague dr. lori wiener i have60 minutes and 80 slides and i can get through them 30 secondsa slide but i only have 12 and i hope that this is going to be anintroduction to the conversation that we're going to and takeadvantage of with our panel participants and everyone that'shear in the audience. so you know people talk aboutthe ps and qs and i was like gosh what is that originallyfor, but i will talk about the
ps and cs of a career inclinical translation research as an introduction to ourconversation. so it's ironic that janine saidshe would describe me as passionate because the firstp-is actually passion and listen, these slides were donethis morning. this was not coordinated. but of the five ps i believeyou have to have in whatever cer path you choose, ibelieve actually, passion is the first thing.
because you you have to lovewhat you do and do what you love. because social security is goingto run out of money way before we all need it. we might be work, much, much,longer than we think and so it's really, really important toidentify those passions because it's been my experiencethroughout my academic and personal life that those peoplewho are most passionate about what they do, and i don't careif they're doing landscaping, i
don't care if they're baking cupcakes, i don't care if they're doing cutting edge science atthe nih, the issue is, is the people who are most passionate,they have the most incredible stories. they have the most awesomeachievements, they have the most powerful impacts and they haveit with an attitude that's really other-focused rather thanself--focused. when there's that true passion. to me true passion always has tobe outward focused rather than
inward focused. that's my first p. the second p is people, whetherthey're patients, friends, colleagues, family, in the endno matter where our technology takes us in this level ofsophistication and complexity, i mean it's absolutely incrediblebecause you can be in the bush of africa and you can downloadthe espn results from your smart phone that's houred by a solarbattery. i mean it's absolutelyincredible the kind of
technology and advances andthings we have at our fingertips to impact our lives. but the bottom line is, is thatpeople and relationships will always be the single mostimportant focus of your entire life. and the context in which you doit, professionally and how you develop and nurture and fosterthose relationships, people alway will be and need to bethe priority. i think if we had that focus inkind of some other areas of our
government where it's not aboutagendas or lobbyists or organizations and it's reallyabout what is best for people and the common good and seekingthat, we would see some differences but people have tobe the second p, the third p is perspective and you know, i likethe left hand slide, it's incredible what can you find ongoogle images, you know, you take a screen shot and boom it'sup in your slide presentation. perspective is so important. i think one of the issues thatdr. clayton raised and that i
hope comes out of this panel isthe importance of diversity and inclusion and diversities ofperspectives. the right hand side, rosecolored glasses, all right? not everyone sees the worldthrough rose colored glasses, some people have green glasses,blue glasses, there are lots of different perspectives but ithink it's so important and we keep understanding more and moreas science becomes truly a multidisciplinary enterprisethat we can't all stay in our silos of i'm eye chemist, i'm abiologist, i'm a physician,
bioinformatics person, i.t.,communication specialist because t issue is that diversities ofperspective allow you to ask some very incredible questions. and allow you to identifyanswers and go down roads that you never even thought of as itrelates to the simple issue of including both male and femalegender animals in preclinical animal model studies. is really quite revolutionarybecause the issue is that we as scientists, we ask thequestions, but the issue is that
if you don't ask the question,you'll not get an answer. i go back to the issue of thehuman micro biome which is now about 10 years old. and you know, we all knew this,we knew we had bacteria in our mouths and our guts, inourinoses, on our skin, you know we were co colonized and soforth, but until somebody started asking, you know, it'snot just skin bacteria, i mean how do we live with thisincredible trillion community of microbes and it turns out thatour microbes are pretty
important. they govern our own universe. the function of our immunesystems, it's absolutely fascinating so, diversity ofperspective really allows us to start to ask some very uniquequestions and get very, very important answers that literallycan revolutionize our world. the np is providence. you know when i googled this,and i googled the word providence, was pictures ofprovidence rhode island and i
didn't want to include that andprovidence for me is that a believer in jesus christ is thatthere are things that happen in my life that i can't explain. people that i run across,opportunities about research programs or opportunities forcollaboration that never even crossed my mind and it's just asimple meeting, just happened to meet somebody, you know in theline at starbucks, just happen to be there at 11:30 at nightwith another attending physician writing notes and get intodiscussions about where did we
even start to then lead tocollaborations and opportunities to pursue areas of research,professional opportunities, expanding the scope ofinteractions and influence and i think providence is all a partof our lives whether you call it luck or coincidence, whatever,there's some things that happen in your life that just allowthings to happen and things to move forward for you. an example of scientificprovidence, i single dr. griff discovery which ishydroxiria which is an
anticancer agent increases fetalhemoglobin that was a dorphy that hide roxyrya can impacthemoglobin but it's been a advancement in sickle celldisease, but you have to look for and too providence in yourrelationships, at work, in your experiments, at the bench. don't throw away all thosethings that the answer to your scientific hypothesis was nobecause maybe there is a providential answer in there, inthe no answer that if you dig a little deeper and maybe ask afew more questions, you might
have additional novel insights. number five is purpos. i think they're all tiedtogether, love that, got purpose. well, you know again yourpassion is tied to your purpose, if you don't know what yourpurpose is, if you don't have a sense of what you really, reallywant to do and purpose can change, but purpose is whatallows you to direct and target and fuel that passion that youmay have and i think that it's
really, really important toidentify and focus on what your purpose is and build that storyand purpose can have multiple chapters in your life becauseeverybody has seasons in their life, you know? my purpose which i was in medcool was especially my first year of med school at duke wherethey crammed the first two years into one year and during blackoctober we had 18 exams in 30 days, it was like get me throughthe next 30 days, sometimes that's what the purpose is.
there are different seasons ofpurpose, if you early in your career, balance and juggle thework life balance between family and your career obligations andaspirpirrations and what you want to do, but purpose again isa great focuser of passion. and it's my fifth p, on to thelast one, when you have purpose, passion, perspective, it doesn'tmatter what you set your mind to or your heart to do, the is shethat once you do that, automatically they're going tobe challenges. there's not a day, not a minute,not an hour not a week or a year
where there's the potential forchallenges, sometimes they're great, sometimes they're small,they come in every flavor and shade of the rainbow, shape andsize, but no matter what the challenge, the issue is i lovethe final sticky note where the impal challenges thateveryone--impossible challenges that every faced and i'm surefrom our panelists we're going to hear and even from members ofthis audience there have been challenges that people face intheir health in terms of getting your long awaited first in humantherapeutic cancer vaccine, made
under a contract, qc'd undercontract through a thousand page fda ind, after three or fouryears begging for funds to finally being able to treatpeople who are resisting very advanced stages of metastaticcancer, there are times when the challenges really do seemimpossible. and you just have to bepersistent, keep at it, keep kluging at it and eventually theimpossible does become possible. and as a matter of fact, what ilove to say is that everything that you see and everything thatwe deal with at one time was
unseen. every single thing that existsbecause at won time it was in somebody's mind and if you justwant to go retroabout 20 years, get a movie from 1980, early1990s, and take a look at the cell phones. they look like a big timber landboota you know that the guy is holding up to his head and nowin 2015, everybody has a video camera, an audio recorder, acamera, gps, they can do their stocks, e-mail, phone, selfies,all the tips and twists who
knows but that was all animpossible: 10 years ago, 20 years ago, everything that wesee now was an impossibility yesterday. and the evidence that it'spossible is that we have it now. so, that's the issue withchallenges. number two is choices. you know there are many careerturns and paths we can make, choices we made, which protocolam i going to do, who am i going to work with, where am i goingto do, where am i going to do my
post doctoral studenturaltraining, i saw the middle sign because there have been choicesthat i have been faced with where i felt like my brain wassaying, exit now, stage left, do not pass go, do not collect$200. this isn't going to work out,it's impossible, but in the end the thing that's absolutelyincredible about us as human beings, and free moral agents,you know dogs gotta bark, fish gotta switch, birds gotta flybut we get to choose what we do in life and with our live whichis is really, really very, very
incredible and the environmentof the nih and the research environment of the nih reallymakes for some very, very incredible professional choices,both personally and professionally. number three c is collaboration,i love this because again it was again, google images, i whippedthis up and they're even matching and it's likeeverybody's got their different little cog in the wheel and theimportant thing is and i think the other perspective aboutconsidering all the perspectives
that people can bring,culturally, from a gender perspective, from an ethnicityperspective, from a professional discipline perspective is--isthat everybody can supply a perspective and there's actuallya chink in the wheel that connects to something else. and the issue is is when peoplebring in their wheels that's what actually makes things moveforward, because whether it's a big wheel or a small wheel,that's how progress is made and the right hand side of theslide, i just love the different
popsicle flavors of the paththat you're walking on. but ultimately, that pan, personeffort when it's targeted and people are in agreement, andactually kind of start thinking, single mindedly about how we canaddress this problem, it's amazing how quickly things canmove forward. it really is. a simple example that's reallynot noble or anything like that, is that a couple of years ago onnew year's eve, new york city got like two and half feet ofsnow, some incredible amount, it
was like 2 feet within the twodays before new year's eve. and i don't know, a millionpeople come to time square and what was amazing is in less than20 hours, time square was clean as a whistle so there could be anew year's eve blast party. now if we could get people incongress to agree about, you know budgets and funding and soforth that quickly within 24 hours, i mean gosh wouldn't thatbe incredible. but that's just an example ofhow everybody coming in and being focused on somethingsingularly minded and make
phenomenal things happen in ashort period of time. number four is my colleagues,you know. i love the rubics cube becausewe're all like twisted around, trying to figure out the puzzlesof the questions that we're trying to answer scientifically,trying to help each other get to the top, you know pulling up theropes, i love the middle thing that said promotions are good,bonuses are better, but working with a colleague like you is thebest part of this job and i will have to say that after 27 yearsat the nih, it is really the
opportunity to work with some ofthe most compassionate, talented, dedicated, brilliantbrightest people on the planet. that has kept me at the nih andit's allowed me to remain and to stay despite the challenges thathave remained and colleagues in the world get bigger and bigger. you start out with the smallworld of colleagues, but it's amazing. there's less than 6-degrees ofseparation and and the collaboration scope acrossins, across institutes,
across countries, across theglobe and the manet and it really makes for a veryrewarding life. the final c is the conquest. i mean that's the reason whywe're here, it is the reason for why we do wawe do. to ultimately be a part ofresearch that really impacts u maneth and makes a difference inthe lives of people who are resisting health challeeven unto death. they are literally fighting fortheir very lives and that's what
the focus of our research isabout. is that conquest. but i put two pictures therebecause when you get to the mountain top and you actually goaha we did it! an example for me professionallyis my involvement with work in the early study ofantiretroviral agents and immune based therapies for immuneinfection in pediatric and adolescents and young adultpatients. when i was in med school therewas no such thing as aids or
hiv. in the latter years during myprofessional lifetime were the first descriptions of the viruswhen i was doing my resdenzy, bob gallow and others here,identified hiv as the cause of aids but it was a deathsentence, it was an absolute death sentence. and then there was a little bitof providence because few investigator's took some oldbeat up bust, no end, not working anticancer drugs calledzivodine, hey, let's pour it in
there and see if it keeps thevirus from growing and voilã€, reverse transcriptors were bornand then the protease inhibitors and combinations of drugs andultimately therapeutic advances such that hiv infection in aidswas transformed from a death sentence to a life sentence as achronic illness in 2015. there are therapeuticinterventions. we used to give people pillsevery four hours, 25, 30, 50 pills a day, now, three or fourmedicine in a single pill once a day: it's amazing what we cando when we get to the conquest.
but the issue is, if you getthere alone, it's really not worth it. when you get to your mountaintop, you need to make sure there are other people that are therewith you because a conquest achieved alone is really not asuccessful conquest at all. so those are the five ps. we got the five cs, here's thelast and final one which is thank you for your time andopportunity to speak to you. [ applause ]excuse me, i have another thing
to do i have the privilege ofintroducing laurel lee who was introduce and talk about thepanel, she's been marathoning for many years regarding thisincredible enterprise that is the nih clinical center. it's amazing what you've done. and and it's a privilege tointroduce lar to the deputy center for clinical care inpatient safety ask clinical quality at the nih clinicalcenter, those of us in the know she's been david henneddersson's right arm, left foot,
right foot, extra head, she'sbeen an integral part of this institution so laura it's yourgo. >> morning everyone and thankyou for that inspirational talk, and including me in this eventas we celebrate women's health week here at the nationalinstitutes of health. i feel like i'm with a group oflong-term friends and colleagues because--right now it's muchbetter, because i've known several of the women on thestage for many, many years and happily now i can add severalnew women of stature to my
circle of stateur and to thati'm grateful to everybody in the room, i was pleased whendr. clayton and bonnie asked me to moderate, i've knowndr. clayton for over a decade, my first and favorite memory waswhen she was a young investigator, or rather ayounger investigator because i swear the woman does not agewith the national eye institute. she was presenting a scientificcoaster at a research event here at the clinical center and withher standing at the poster was her amazingly elegant mother andwhat struck me most about that
day was how unabbassedly proudeach of them was of the other. it was just two women generallyleaning in, i have never forgotten that. i will carry it with me. and here we have a stage filledwith women who are each making remarkable contributions forscience, patient participant experience and to the health ofour nation in our world. i came to the clinical centerlike many of the people in the stage, 30 short years ago,nearly 30 short years ago as a
relatively new iners, notknowing what to expect of this research institution but ilearned several important lessons over those years. first our care team members hereat the clinical center are the most dedicated professionals iknow. they possess the rare ability toprovide compassionate and save patient centric care whileseamlessly managing the requirements of complex clinicalresearch studies. second are victorys who areresponsible for saving and
improving lives of these people,do what they do so well in the faces of every mountingpressures. and finally patient participantwho is come here from all over the world to volunteer fornearly one--1500 clinical research studies ongoing at theclinical research center are truly genuine heroes. i also learned at my work herein the the clinical center that the delivery of safe andeffective care and high quality science is truly a team sportwhich himly can't do the
work--simply can't do the workwe do without the engagement of our patients. the theme of this year's healthweek is faces of research beyond whereas many of us in the roomequate inclusion with insuring that our research studies havethe appropriate equation from diverse population which istruly important, i encourage, i think i challenge you to broadenyour thinking to inclusion to include the active anddeliberate engagement of participants, our heroes in allaspects of their caring research
and imagine how care and sciencewould be improved in patients certificates were engaged earlyin the design of protocols to insure their physical, emotionaland mental experiences were taken into account. it would lead ultimately tobetter scientific outcome or imagine how we could reduceerrors in harm in the hospital setting if our patients wereactively engaged as members of clinical center committees andteams that were working on ccal patient safety andquality issues and finally one
can only imagine that ourcollective partnership would be enhanced if patients wereengaged even after their studies concluded by routinely providinginformation to them about the outcomes of the studies. just imagine three simple shiftsin our thinking lead to better patient participant experienceswell as well as better science. let's meet that challenge and nobetter way to get that started than to meet the women that canmake that happen. so let's welcome ourprofessionals and our
volunteers, i will dointroductions. so i will ask that you raiseyour hand or wave when since we're not sit nothing any order. so our first clinical trialvolunteer is jamie b entilly, she was infect wide a bloodtransfusion, she joined her first protocol in 1990 and hasgone and since gone on to lead a happy and healthy life. she has a bachelor sciencedegree in biobehaviorial health and master's degree inbiohealth.
she's works in northern virginiaand lives with her husband of nine years. in 2013 she published her memoryresponse wor,--memoir, she titled: growing up hiv, live asecret and living positive. our next volunteer isjuliana,--in 2010 juliaiana and paul learned about the bonemarrow transplant research program at the nih. own natter nightly becomes priorto becoming a participant, paul passed away from sickle celldisease, after the successful
completion of her transplantjuliana made the conscience decision to trade the life of acertified public accountant to the life of a registered nurse. sorry about the income dropthough. [laughter]anyway juliana completed her first year as a registered nurseat a community hospital and hopes to work with children inthe near future. juliana plans to remain anactive participant in the nih sickle cell team, and hope to bea positive influence so welcome
juliana. our other volunteers, scott isable to be here today but we would like to thank her foragreeing to volunteer and hopefully she can join usanother morning. so let's move on to theprofessionals, dr. amina white is a faculty member in thedepartment of bioethics. amina's work focusesot study ofethical challenges among physicians during training andin clinical practice when caring for vulnerable patientpopulations while handling
office pressures and timeconstraints. her research includes patientphysician communication in the era of electronic healthrecords, patient activation and engagement of disadvantaged ormarringinallized patient groups, trauma informed practices andobstetrics in gynecology for women who do this, related toissues of pregnant women, welcome dr. white. in addition in her role at theclinical department, dr. adrian adrianfarrar is retiring soon, in
addition to her work as a socialchair, she is with the lcwsw-c, throughout her career, she hashelped social work, physicians and public sectors of geriatricsocial work and healthcare. prior to joining nih, she wasthe director of the social work department at the hospitalcenter in washington. she's a member of the nationalassociation of social workers, board member of social workersand member and former society for national work, social workand healthcare. welcome adrienne and lori is theco correct director for the soak
o social support and researchprogram at the national cancer institute here at the intramuralprogram. in this role dr. wienerdeveloped a research program that focused on critical issuein the hiv field including parental needs and coping,children's distress, diagnosis disclose and you are loss healso has been active in helping manage our pediatric oncologyissues, parenting, medically required isolation, siblingdonor experiences, graft verses host disease, distressedscreening and end of life
planning. she has also dedicated asubstantial part of her career to apply science andpsychosocial studies through creating innovative resourcessuch as work and gain for adolescence in the adults. welcome laurie and our panel. so as janine said this will be aconversation. so i have a few questions to askour panelists, but anyone who has a question or someone whowants to call in, go to the
microphones we want it this tobe a discussion among friends. i will talk with our volunteersand ask the question, have you briefly describe to us why youdecided to participate in a research study or or at theclinical center or elsewhere, and either jeweliaba or jamiewho whoever would like to go first. i know you're not shy. od morning.re not shy. i guess i wasn't as much of anactive participant in the
decision to come here as it wasmy only choice and back when i was diagnosed with hiv when iwas eight after realizing that i was effected of age three--isthis working, there were no hiv at all.ptions for kids withand it was literally a deth sentence and the doctor told myfamily, she's got two years to live and miraculously two yearslater we got the news that nih was opening up a study, aclinical trial for pediatric patients living with hiv. so it was really--it wasserendipitous, it was
providence. >> providence,. >> absolutely was and it was nodecision for my family because it was the only piece of hopeand any kind of vision for any kind of future that i mighthave. so i was 10, so i did what myparents told me to do and they did consider, you know is thisgoing to be a life that will be good for her? it's a lot of clinic time.
it's a lot of test andprocedures, so they certainly considered that but it wasreally, it was a miracle that came cathly when i needed it. >> i guess, for me it was more iwas tired of living with sickle cell anemia and it was not aproductive life and i wanted more for me and my brother. but you know they--there aremany things, you have family members, i'm originally fromnigeria and you have to try this and this and you pray foreverything and doing this and
none of those worked and i justgot tired of it so i just kind of accepted that's the way itis. but one day it was so funny, iwas coming back from work, this was when i was an accountant andone of my friends gave me a number to some, to a nurse athoward university hospital and she's said just call her, thatshe heard about this research that they're doing at nih, i'mlike, okay, sure, so i'll do that and that kept the numberand that same day, i went to visit my parents and my mom wason the phone with another--one
of my aunt who was telling mymom about this girl that had sickle cell disease and she wentthrough the trial and she's much better now so my mom was youhave to talk to, you know this person, i'm like mom, okay,sure, whatever, so i took the phone and my aunt gave me thenumber and i wrote down the name and the number i'm like okay,thank you. so when i went home i took frommy pocket the same number that my mom, my aunt gave me, andthen the other pocket, the information that my friend fromwork gave me and it was
identical. it was totally to contact thissame nurse, this same number, okay this is not a site and i'mreally dumb, exactly. so, i'm like, okay, well, i haveto do this, so, then i contacted them and that's how they got mein touch with beth link and dr. shea's group and we wentfrom there. >> great, thank you so much. so i want to talk about theconcept of engagement. so we did a study of researchparticipants perception of their
research experience and one ofthe findings from that survey study was that participants andfacients felt there were active members of the research team andway better over all perception of clinical research, can eitherof you or both of you will be great to comment on your feelingof engagement, your feeling of being a partner and if ithappened, what that meant to you, it didn't happen, and ifyou can talk about that? >> i think it's as i grew up inthe clinical trial setting my level of engagement evolved,being a kid when i started, it
was not quite as involve as mayparents were involved in this process and they were making theinformed decision, as i got older and i started to sit downand look at the protocols before we signed them, then i got moreinto it and it was fascinating to me that all of this had goneinto what they were doing and the research settings. and i remember dr., you mightremember this, we were sitting and talking over new protocolthat was coming up that was very promising and i think i was 14or 15 and i got so overwhelmed
that i started crying and it wasthe first time that i was really involved in my own care and youmight think this is a bad thing but it wasn't. it was good because it opened myeyes to this is my life and i can have them say in it and someah town me in it and from that point --i became an activeparticipant and it made an engages experience for me and myfamily and it goes along with the philosophy that my momraised me under is advocate for yourself, advocate for yourkids.
so that became how i continuedon the journey at nih and i think when i was younger and myparents were the ones make--primarily making thedecisions i think they would have been times to be moreinvolved in the process to be very honest and i think that hadto do with competing priority research and the needs of thepatient and i mean looking back in retrospect, there could havebeen some better more engaging conversations that could havebeen had with them but for me, it was always a positiveexperience.
>> for me, it was very easy. it wasn't something i had tofight for for my voice to be heard, for the team i workedwith, they were just wonderful. they were very caring and theymade sure that they took the time to make sure that my needswere met or my concerns were addressed and my questions wereanswered and and i guess, you know the way i look at it,it's--i'm not doing this you know for me getting thetransplant wasn't just for me, it was for my brother, sowhatever i was trying to--at
times i was like okay is thisgoing to work right after my transplant. i was told it may work, it maynot work, you just don't know. but regardless i went for it. but i think just i had remainpositive. i was very--like i would getdiscouraged thinking okay, it's been a year and i'm getting sickand i'm getting more blood transfusions than i got before. but i hung in there and myfamily was supportive and the
team was very supportive and iguess, you know it came naturally and as time went by igot more and more better and then i got more and moreinvolved. and i think last year they askedme to do this little snipit about you know my experiences asa transplant volunteer and i didn't hesitate. i was like, yeah, i would loveto do that. whatever i can contribute tomake it known to other people out there about sickle cellanemia or also about the world
about this disease, i was allfor it, so for me it waspt something that was anychallenge. it became really easy for me. so ... >> and could the--i can call youthe professionals but i'll say the nihers, can you each commentabout your role in terms of engaging, how you see your roleof engaging patient in their r and care to make surethey do have their voice. these are two women who clearlyhave their voices but i'm sure
that each of you in your roles,social work, run up against patients that may not have thatvoice. lori you want to start? >> sure, it's a critical issueand there is an emerging field of what we call patient-reportedoutcomes where we want to be able to make sure that thepatient voice is heard so that even for symptoms of pain,fatigue, anxiety, sadness we're not just asking the parentsabout how the child is feeling, will ask that as well, but wewill be able to make sure we
have the child's voice as well,from throughout the treatment and their time here and npr thismorning on my way to my hour and half commute to work, there wasa piece on stroke and depression and the reporter quoted aphysician that got in the middle of this, that there's no helpwithout mental health so it's truly the way that i practice,that the child's mental health is critical. the family's mental health iscritical. and if we don't address that,you will not have it here and
you will not have people whowill be participating, you will not have people functioning,well, the challenge in pediatric system when to involve andengage the child and we really have to respect the familiesbecause every family is different. every family comes in with theirown norms and beliefs. we work with families to be ableto help them, to be able to provide more autonomy to theirchild, especially if they become teenagers to welcome withtransitions be able to
transition to adult care. when have you a child with achronic illness, that becomes difficult, families are veryinvolved, people perceive them as being involved, almost lostthe child on numerous occasions so they watch everything. unfortunately, sometimes thechild then doesn't become prepared to have their own voiceso we're very cognitive to that but also respectful of thefamily's choices and decisions. >> let issue of patientengagement and voice is very
serious here at the nih so thedepartment of bioethics is part of a service, offers a servicethat can help participants who lack the ability to consent toresearch, make sure that their needs and safety, it's reallyprotected, if they are in fact participating in a researchstudy. so for example, amount ofexperience a member of the ability to consent assessmentteam and there are study tag are ongoing here at the nih thatinvolve patients with alzheimer's disease or dementia,and times the investigators
aren't quite sure if the personwho is a potential research subject number one understandswhat's going on with the studying and some of the risksand benefits of participating and number two, that you know ifthey have any reservations about joining the study that theyeither can decide for themselves how they feel about thedifferent components or that they have an aappropriatesurrogate decision maker to help think through some of thoseissues and make sure that @ end of the day, researchparticipation is in the benefit
of that individual or otherindividuals who can be helped by the research and so we take thatvery, very seriouly and we conduct things called capacityassessments of individual potential participants and alsohave conversations with family members who may be serving assurrogate decision makers to make sure that we really respectpeople's choices and their overall well being as theypartase participate in a trial in the studies here. so in the social workdepartment, i wear a few hats
because we have a few programsunder our umbrella, social work programs, we're also responsiblefor the language interpretive program, and for the volunteerprogram. so i have to pay attention tothe voices of patients from a number of differentperspectives. what's interesting is in oursocial work world, or in our training, listening andobserving are very important schools to our practice, it'svery important for us to listen to what the patient is saying,to observe their behavior, in
terms of what they are doing andhow their families are doing and many, many times to help theminterpret as well as for us to interpret to the rest of theteam what they're feeling, what they're actually saying, themessage that patients often give to their healthcare providersblood sample it's a doctor or nurse, they could be two verydifferent messages and by the time we see them, there might bea third message and so it's very important that we continuallyengage with team and the families to make sure that we'reall on the same page in terms of
understanding what that patientis saying, the reason why the language interpreters areimportant to this process also is because their role is notjust to interpret what's being said but they have a profoundknowledge of the culture of the individual they're working withand they're able to do brokering which again helps us tounderstand where the patients are coming from as well as howthey view healthcare and how they review involvement withhealthcare professionals and again because we're highlyempowered have individuals who
know what they want and have noproblem asking for what they want, that is not the case withmany, many other cultures, physicians and nurses arereferred, they are not challenged, what they say goes,so it is our job as the interpreter as well as socialworker to make sure it's--that the team understands where thispatient is coming from and how we can work together to empowerthem to have a voice. for those couple of areas thatwe come from. >> adrian would you mindcommenting, last year we had
really the honor of bringing acohort of family from uganda for a study here and it was a greatopportunity to include these folks in the research study andcertainly different for us as an organization dealing withcultures and languages and. do you want to comment about thebarriers and languages, and bumps in the road we met withthat experience and how we have resource we had resources tomeet that? >> as you know it was atremendous a mount of preparation within the institutefor a number of patients who
mostly belong to one or twofamilies, about 10 or 12 individual who is came and theinstitute had done quite a bit of work, at the time when theyknew they were coming and they engaged the clinical centercoming with them but not in enough time for the languageinterpretative program to find the interpreters of the languagethey spoke if that culture. the language of acoli, thebrother or sister language called achould, but seem tounderstand each other, we didn't know until we had a recruiter.
but there was speakers betweenthe speakers in ugand and so even as we brought in theinterpreters we had to insure the family members who wereindividual who is were interpreters were not hostile tothem, so how would we have known this, we had no way of knowingunless we were open, listen to what was being said by theinterpreter with regard to the questions that were being askedof him. who's your father? what did he do?
where did he live? so it was clear. so that was game on. >> it was a lot of challenges. >> right. it was that patients came herehad had no proper clothing, had no shoes to get on an airplanewe didn't know what they had to eat, we had to investigate allthose kinds of things and we were here for a couple of weeksso it was an intense period of my life and hopefully will neverhave to go through that again.
>> in the next six weeks. >> yeah, and i think--it was agreat example about how this place can garner those resourcesto meet a really challenging and vulnerable population. so i want to go, these guys sortof had questions ahead of time but i'm going to go off script. so could jamie could you talk tous about the process of writing your book and where that camefrom. because i love the title andincreeinged by your journey of
that. >> when my journey started outas the book says, tell friends about, we told only closeimmediate family members, we at that point had moved to a smalltown in pennsylvania, and it just wasn't something that youtalked about. so it was a secret. and as i grew up i kind ofwanted to be more open with my friends, you form greatfriendships in high school and college, so at the end of highschool, i decided i want to tell
people about this. i want people to know that hivexists in our world and that you have to be careful so i had aschool assembly the day before graduation that no one knew whatit was for and we were doing graduation rehearsal,rehearsing, walk nothing a line and my friends and i went tohardee's for lunch and they said we have to go back to school forthis rehearsal for this auditorium assembly and i'm likei don't know what a drag! [laughter]so we get back and i sneak back
behind stage and i give mypresentation and it was strategically done right beforegraduation in case they came at me with pitch forks and i had toleave town and i could go to college and escape and i was theyoungest kid in the family and they could escape if they neededto but thankfully it went well, so that was my first experienceof public and talking about this and being open about it anddeveloped more and more in college and as i became morecomfortable in my own skin and decided that i could be be openwith this with people i met and
then going into the workingworld and meeting my now husband paul was really the turningpoint for me that i found somebody who would willinglytake this on and deal with this for the rest of their life. my family didn't have a choice,they're stuck with ti didn't have a choice, i'm stuck withit, but this guy is makinga a conscience decision to spend hislife with me. so this help mood in helpingfinding the other person to be comfortable approximate with andtalking about hiv and i got that
point they want to write mystories down, and i have these amazing experiences at nih and ihave a lot of stories in the book and it's all positive. [laughter]but i decided if it's my niece and nephew to see the story oftheir ain't, i want to get it on paper and start writing it so iwrote when i felt like writing i didn't and when i took threeyears and i didn't do it chronologically, i wrote aboutwhen i was a teenager and i wanted to write about that so itwas a slow organic and slow
process for me and i realizethat it might have the potential to help other people and helpthe field of research and field of healthcare so when ipublished it, i published it through amazon, it was kind ofthe--with the disclosure, you can't rewind, once you get itout there, you can't get stuff off the internet, people, itwas--when i submitted it, the year book and now for sale. okay. so that was kind of the--anothermoment of a new step and so far,
so good. and after that, it's been--i'vebeen able to do things like this which i realize is what i'mreally, really passionate about and i'm so grateful to havesomething in my hand and hold and say this is my story and irecommend it for anyone. it's such a good story. such a cathartic process ofwriting it out and processing through things and rememberingthings i had forgotten about and it comes back so clearly and iremember that day at nih when
the nurse was bat man and iremember, it was so therapeutic and so cathartic and somethingthat i'm proud of to have as kind of a little piece of mystory so far. so yeah it's been one of mygreatest accomplishments. i feel very proud of it so i dolike the idea that i can pass it on to people and they can readit, my niece and nephew can read it. my nephew is now 11 read thetitle, he's like surviving h-i-v, they're grateful for theprocess.
[laughter]so i feel grateful for that entire process. >> juliana can you talk with usabout your decision to leave the world of business and go intothe world of healthcare and how your experience here may havealso influenced that? >> i never wanted to work in thebusiness world. i wanted to be a nurse from theget go but unfortunately, i couldn't, but as a child, theparents give you five choices, doctor, lawyer, nurse,accountant and that's it and
anything else, don't even come,don't even like step foot and say, dad i think i want to be adancer or an artist. no. you can't do that. so, the other, you know thefirst three were out so the only one was i guess as anaccountant, so looking at it and sit down and work and up anddown--i thought it gets easier but it didn't. i found myself having to workfour times as hard as the next
person because by march or aprili'm done with all my vacation, all my sick leave because it'sspent in the hospital and i'll see getting promoted and i wasexcited and then next thing i know i get down sized, i getlaid off, of course it's hard to prove that, you know, to provethat the reason why, i'm getting fired again or laid off wassimply because of my illness, but it was something that iaccepted and--but as i grew older and older, i went toschool and got my masters in taxation and now at least maybei'll get some more respect, like
more of a managerial job butthen again sickle cell anemia doesn't care. it will come at any time, samewith this illness, it's very unpredictable, can you doeverything right and then one day just happy go luck schethenext thing you know you're scream nothing pain --screamingin pain in the hospital for days or weeks. i remember when i was in thesuburban hospital, because that was one place i went, i willhave one arm strapped with
transfusion and in the otherhand, me and my laptop try to do tax returns, you know? because if i didn't get thetaxes done, you know i have a deadline to meet and my nursesthey're like oh my gosh, how could you do this, you need torest but i'm like yeah, who will pay the bill, i understand wherethey're coming from but at the same time i have to make aliving. i have to--you know do things ihave to do because next thing i know if i don't this, i will befired or laid off.
so that was pretty much my life,coming to work, three or four weeks i'm good, and the nextweek i'm out and the next week i'm getting laid off so it'sjust like that. and finally until the story itold you earlier how i came to nih and everything. so that happened and i was soexcited and my--i told my brother, we were just like oh mygosh, this is a turning point if this thing does actually work,it's a life changer, and it's funny because we told mysiblings i have seven--i have
six brothers and sisters so itwas five of them that had to go in and get tested. and each one of course, theywent in and they were not a match. everyone went in not match. so we got four no matches andthen finally my oldest sister went and i was at work and then[indiscernible] called me and she was like i got the news forfrancisa, and she said she matched she also matched yourbrother and i thought are you
kidding me? what? so it was just a turning point. i'm like oh my gosh, okay, thisis it. this is a big sign and mybrother and i were so excited, i did everything, i told my bossthat you know i just need few months off to get thetransfusion done and they were happy or so i thought and thenwhat happened was after i did all the preparations andeverything, i got sick again and
they told me that i had to cometo work. so that thursday, i checked outof suburban hospital, went back to work, and then they laid meoff on friday and they said, they just gave me a stupidrson that didn't make any sense to me and then i was likeokay, on friday, i call my brother, i'm okay, pearl i knotlaid off again, let's fight it and let's go see a lawyer, soweb connected went on friday to see a lawyer and then onsaturday i got sick again went back to the suburban hospitaland on sunday my brother was
supposed to see me, he didn'tcome by, i'm like what's going on and then on monday, i saidwhere's paul, where's paul and that's when i heard the news hepassed away the day before and that was just a turning point. i'm like okay, i'm done withthis accounting world that i didn't even want to go throughwith this transplant, i didn't see the point of it because i'velost my other half, i can't do this without him. but then when i saw my mom andwhat it did to her and my dad,
you know they lost a child andhere they are about to lose another one and i just couldn'tdo that, i'm not a mother but looking at her, i can see that,i could see that you know she was just, you know she was justdesperate. she would do anything for me togo thraw this transplant and so, because of that i decided to gothrough with the transplant and then after the transplant itworked and i'm like, okay, you know what, the accounting worldi'm not going back, i will make a conscience decision to be anr. n., went through the
accelerated program at johnshopkins and here i am a year and half later. it's awesome. [ applause ]>> thank you for sharing those stories, they're amazing. any questions from the audiencefor a second before we move on? >> i have a question, it soundslike neither of you were in placebo controlled trials. do you think it would have beena different experience for you
if you were? [laughter]>> for sickle cell anemia, i don't think there's a place forplacebo. it was just--it was one way,it's either you go through the transplant, you know hope to godthat it works and you're cured or not because it's not anillness that you want see oh is this person, if this thing willwork on this person or not? you know what i mean so forplacebo i don't think there's a place for sickle cell anemia, ifit's a drug that's different but
this transplant is either or,you know what i mean? i hope that answers yourquestions but there's no place for placebo. >> yeah, that's an interestingquestion, i've never really thought about it, actually and ikind of along the same lines, even though it was a drugprotocol, i can't really imagine it being a placebo, goingthrough that. so yeah, that's a good question. >> dr. white would you like toway in on that from your
perspective from an ethicalstandpoint. >> the question of howparticipants who end up in the placebo arm of a trial whoexperience that is definitely an important question and achallenging one because part of what goes on in the process forplacebo control trial involves a discussion about the potentialbenefits of that trial and what randomization to one arm orother might mean and it turns out that's an incrediblydifficult concept to scribe in a way that is meaningful forpeople for the reason for which
they're pursuing studyparticipation, and it's hard for the investigator to know thatwith confidence that somebody's not deceived into thinking thatthere's technically a 50/50 chance with the arm of theactive drug oppose to the placebo arm and yet to be ableto conceptualize what it might mean if you are in that placeboarm. it's very challenging to studyeven through qualitative research to get a sense of howpeople understand the concept of benefit and these are thingsthat we are trying to tackle in
the department of bioethics forexample. we have a number of facultymembers in our department who work on issues around conceptand ow participants understand that and how val unsupportedtears conceptualize randomization and how we canexplain those things better so that people can actually make aninformed decision that is meaningful for them when thereis a placebo control trial. >> it's an excellent questionand it's one of the first questions to be ask canned, ifmy child be a guinea pig, will
there be a placebo? and for those to be educated isthere a cross over study, so that [indiscernible]. --for many, many[indiscernible]. >> while have you the microphonein your handa, could you talk about the challenges of engagingpediatric participants in the research piece and one thing toengage them in your care but to really engage them like jamiedescribed at age 14 she then got engaged.
how do you engage younger kidsand do you engage younger kids in the research process so thatthey have that broad range of >> it's an interesting question,it's one engaging them in the research but the other part isengaging them in their healthcare. for many children who grow upbeing sick, they don't understand life differently thantheir life as it is so overtime it's helping them to be able tocomprehend and understand what it is they're living with sothey can become then more
engaged in the healthcareprocess. there's ascent and dr. white canspeak to this in more detail that most protocols have, thechildren actually have a document that's written fortheir age and development that they can be able to go throughto make sure that they understand what it is that theyhave to be able to go through. so in terms of research from theparents point of view and then for the children. parents want to know is thisgoing to be safe, what are the
benefits of my child, what arethe risks for my child. how much time will my child haveto be aware from school. what about psychologically. how will this impact them? and kids pick up from theirparents, if the parent is stressed about a study orprotocol, remember this, child's not going to be comfortable inthe research and the more stress that the child seems to be themore unlikely a parent will want to be or is for their child tobe able to tis participate in a
trial. --participate in a chyle. the way everybody works andkeeps their own book and every time they come they write apage, they have workbooks, they do a page of the workbook sowhen they look back over time they can see what they gothrough at the age of 10, 11, 12, 13, they may laugh at theirfavorite color, tv show at that period of time. who that family member or friendmay be but it's a journal that's
we try to be able to help themto document so that they can understand over time not onlytheir illness and but how engaged they want to be and forsome, they want to be spokes person and for them they wantsto get this period of time in their life but engaging themfrom understanding their disease and then being able to engagethem in medical decision making is a process that takes place. as people age. >> anybody have any otherquestions in that regard.
switching gears a little tofocus more on women's issues, maybe aminna you could fieldthis one. from your perspective why is itimportant especially with all the work you've done with womenin your research and women and women of diverse backgrounds toparticipate in clinical research? >> so, you know we're hereduring this important week, sort of recognizing some importantgains that have been made including women in research andas dr. clayton mentioned right
in the beginning, part of thereason this is so important is actually a scientific one andthat is that women differ from men on a host of levels all theway from, you know physiology, the way metabolism works,hormonal differences, down to the level of the dna and tounderstand how a particular drug or therapy is going to effectcertain kinds of people, requires that those groups whoare likely to use and benefit from that therapy and happy beenclouded in the development of the therapies and the testing ofthose therapies to make sure
that you know not only is a drugor intervention a safe one and an effective one but at whatdose. questions like that, can't beanswered if you don't have the questions and don't have theperspective that includes groups that may be overlooked. so, now that we've made greatstrides at including women in the cohorts that areparticipating in drug trials, there are additional challengesthat we still need to to resolve and improve in terms ofincluding women of different
diverse ethnicities in trialswhich i'll say a bit more about in a second but also women atdifferent stages of the life cycle. and i really look forward toprogress that's being made in that area. one of the issues that i am verypassionate about as an obstetrician myself is theamount of research that we have yet to do to understandeffective drugs and dosing for the entire population ofpregnant women.
that's a group that is veryoften less out of research studies really on a count oftrying to protect the safety of the developing fetus. and yet if we don't find a wayto include women at that stage of life in studies aroundtherapies that they really need, pregnant women get sick and needto have drugs that are well studied and effective and at theright dose to be effective, without including them we won'tever know and clinicians will not have a appropriate evidenceto make good decisions in, you
know in the hospital in theoutpatient practice when women do get sick and around thatissue of ethnic diversity, again this is based on where peoplecome from and their exposures, there are changes at the levelof dna expression that we need to understand better so thatgroups again who are likely to benefit from a particularintervention can with confidence know how a drug is likely toeffect them and others in groups, in their geographic orethnic groups. audience?
>> morning, morning. i'm rebecca goodwin, i work atthe national library of medicine and one of our researchdivisions and among the activities in which iparticipate, i am currently surveying on our minority healthand health disparities subcommittee and first of all iwant to really thank you all, all the panelists for being herethis morning and the phenomenal, very informative session. thank you.
and i'd like to invita any ofyou who are interested in doing so, to comment about how atvarious points and junctures in your journeys the person andprofessional for all of you, when you encounter challenges,tell be interesting to hear about in hindsight what some ofthe information resources you feel would have been helpful toyou at that time. >> i will take a stab atanswering this, i think what your question brings up one ofthe biggest things that i am passionate about and that i'velearn friday nih is that there
was no information resource thatwe were the train tracks for the train that was just behind us, isay we because, you know ... but i--i think that that's why ithink it's so important, it goes back to the purpose of why iwant to be involved in this and why it's i think it's importantto keep going with it is that there are some areas of studythat don't have a resource to refer to yet. so that's in my experience andkind of being on the front edge of hiv in kids and going fromnothing to something.
and then who knows where we willbe in another 30 years. so my biggest resource alongthat journey was my friend lori here and my mom and supportingthe psychosocial part of things as we started to navigate thisvery mysterious journey. >> to me, i was told i wasnumber 18, patient 18 for the bone marrow transplant that i'vedone and when i heard that, i was like okay, where are thefirst 17, you know? where are they? are they doing okay?
are they still alive andkicking? can i meet them and i guess withhipaa and everything, you know it's just like thisconfidentiality thing. so it's really hard for you toget any information, you know? and when i heard that, that'sdisappointing because i have so many questions there, 's so muchthat the doctors can give you that i want to see someone thatthe actual participant i've been through this, i have my ownquestion, i was fortunate enough to meet, i think she was maybepatient number 15 and she came
up and she had hers two yearsprior to mine and she was doing really well and she was kind ofmy greatest resource, you know. unfortunately, she wasn't aroundenough but at least i got sing from her and and i didmeet another guy during one of my chemo sessions that i washaving, that was pretty much it and he also told me he wouldlike if there was some kind of like, i guess support group, youknow that nih had you know by the people that been throughthis and come together. that's a great idea, that wouldbe really nice but going back,
maybe people don't want to becontacted or they just say, okay, there's no focus groupthere so why should i bother. but for me, what i did, i tolddr. shay and his group, patient number 20, 21, come ncall me andi'll be happy to come in and talk to them and i've done thatfor 22 other patients and they're grateful for me doingthat that i was a resource for them and that's why i'm doingthis talk and this session because we need to get the wordout there. you know it's not just, you comein and i'm truly like nih
changed my life, this is asecond life for me and you know, there are people out there thatdon't know about this. and word of mouth is thegreatest, you know? is the best, we kind of forgetthe word and at the same time people don't know, you know,they don't know. so it's really, we should find away to engage people there in the participants that are kindof like keep in touch for future participants because that's theonly way we can keep this thing going.
>> what i was going to say is,part of your question sounded to me like as a colleague or as aprofessional how does one stay in touch and in-tune. is that part of what you'reasking as well? >> yeah, i think theorganization that we're in, supports and and does quite alot to kind of force us to really be engaged with ourprofessional group whether they're local or national oreven international. i think in terms of resourcesand where i look and have looked
across my life, in one way youcould sort of come to nih and think of yourself as sort of anisland unto yourself. you're on what we call either acampus or reservation. we're federal employees, and sothey're not a lot of us in our professions in this environment,that kind of thing but because we are a learning environment,we're always looking for what's new, what's on the horizon, whatare people doing that we're not doing here. what is it that we can tellother peal about what we're
doing here, so a huge resourcefor me across my career has been the network of social workersand healthcare whether they're local or national. we have the best library in theworld as far as i'm concerned. easy, at-your-disk access so canyou get all the reading materials that you want or need. because we're an academicenvironment we have all the opportunity in the world to talkto our colleagues as well as other professionals andprofessionals in the
organizations, it's continuallylearned so i think the--that's probably why i've been here aslong as i have because it's constantly an opportunity forstimulation is what you have to do to stay on top of your gamebut it's also what the organization is about in many,many ways. so i hear what you're saying interms of needing the resources and having to keep move nothingthose areas. >> so from a patientperspective, i can't agree more. it's the most important contactand able to be another, so for
those patients that are quiteable to have the internet and read the data and find that someof the patient his had not survived going into treatment isvery, very scary and because of that it make its challenging. so we work really hard toconnect patients with patients if that's something they want tobe able to do whether it's through support groups. here at nih is challengingbecause people don't live close, they're all over the world soit's not like we can have a
local group, meet you wednesdaynights and it's telephone sort for kids, siblings, grandmothers, grandfathers. i have a bereavement group thatmeets monthly to try to get through the first year. professionally it can be alonely road, i agree, and dr. wood and i have spokenplenty about this. there are so many more resourcesnow for women scientists but there haven't always been. you know i live in two worlds.
i'm trained as a social workerbut my work is really that as a clinical psychologist, so peoplethat i trained and are out there performing and jobs right now aspsychologist because there haven't been until morerecently, social worker who is are really trained in doing thekinds of behaviorial science research that we do here, so,more resources could be helpful to get through the last 29years. but having colleagues likedr. wood and others here, have made that possible so i lovethad slide you had up here.
but for other professionalsbecause this is so important, the job, created somethingcalled the pediatric oncology professional web site whereanyone who's involved in psychooncology can get onthrough our own web site and find out the newest articles,newest resources, new conferences going up, newaccreditations going up, job opportunities, fellowshipopportunities and we updated quarterly so that, you know partof our job is to make that available to the rest of theworld.
it's a very big world feel verysmall. >> and just to piggyback oneverything you just said about some of the professionalchallenges and the need for networking and sometimes whathappen - -happens when there's alack of that. i found in my own professionaljourney that being able to commiserate with peers isimportant. just more than complaining aboutthe process or the challenge itself, it's knowing that you'renot alone.
and that this isn't someobstacle that's just unique to your path and knowing that otherpeople have had similar challenges, and just hearing howthey work through them or are working through them at the sametime that you are can actually be very, very important, veryhelpful, you just don't feel like you're crazy and you knowthe process is what it is, can be very helpful and the otherthing, you know beyond the peer networking is mentorship andtrying to develop relationships with professionals who are incareer paths that are similar
but you know may have alreadyprogressed much further in their careers and being able todevelop some type of relationship with individualswho can mentor, i think is sometimes overlooked but veryuseful kind of resource to have. again it goes back to people atthe end of the day. >> hi i'm allison davis and i'ma writer that's been working with nih, for several years. so i drank the cool aid butthank you, i want to thank everyone for coming today,patients, everyone here, this is
so important to hear thesevoices and in such a passionata way. i feel like when you got on aplane people should clap and say thank you for your servicebecause in addition to you being helped, everyone else is helpedand i feel passionately about i'm curious, that said, what'sit like when you leave the nih bubble and interact inparticular juliana and jam scheyou urnt act with yourfriends and family, coworkers, you talk about nih.
i kind of feel like this is thebest secret that we don't want to be a secret. do they know what's going on? what do you say to them? do they understand? if you could share maybe justsome thoughts about what people know, how they feel about it andwhat the reaction is when you tell them about your successesand challenges? >> to me, i will tell it toanyone that will listen.
i'm like, want to hear my story? my thoughts? oh let me tell you. [laughter]but it's funny because when i tell--when people like, myfriends that know me, they're just amazed. because they know the julianathat hospital, all the time, it's like if i can't come to apty and disciplinary not call you, the only other place i'm inis the hospital, that's just the
way it is, you know? and to the point that you knowit's part of the way--it's always been, you know? if i say i'll be there for you,i'm going to come pick you up, if i captain make it because idid a uturn to the hospital, that's just the way it's been. but now after getting thetransplant it's just a 180. you know? turn around for me.
it changed my life. and my friends they just lookback and they're like oh my gosh, they still in awe, theycannot believe that this thing worked. that i'm here, living andkicking. and then what i notice is i havea friend of a friend, i will call someone up and i will say,hey, i have this friend of mine that has sickle cell anemia cani get information and that's--i pass it along.
i just get them, you know incontact with the team that worked with me and that's whati've been doing. so for me, it's, like you say,it's a secret but it's a secret i want to shout off the top ofthe roof tops, you know? and i want to let people knowand it's just amazing to me, like people don't know aboutthis. and i'm like, when i look back,why didn't i know about this? it's been going on for years. but you know, people don't talk,they don't want to listen, then
you won't know, if you know thetwo friends that give me those two pieces of paper, they didn'twant to talk, i wasn't willing to listen, i wouldn't have foundnin so i have to be willing to talk, listen, share, theence but you have to be willing. so for me they're amaze i'lltell it to anyone. so, that's my experience. yeah, i think as a kid like ithink of my experiences, my kid experience and then my nonkidexperience.
>> are you afraid to use theworld adult. >> i'm extremely mature, whatare you talking about? [laughter]it was a big mystery because i would go back to school after acouple weeks of being out and i would say, oh i'm in thehospital because of a heart condition which wasn'ttechnically lying so it was like big brother, back then becauseit was a big secret that we didn't talk about. and then once i started becomingmore open with people and
talking about having treatmentand being hiv positive and coming to nih, i think peoplejust i got the sense that people just thought it was a reallyimpressive place that they had no idea exactly ha happened orwhat went on here and they would never know that, yes we're doingthe most ground breaking research here and we're alsothrowing halloween parties for kids and everything in betweenand i would come back from my days at nih and spending time atthe children's inn. it was great.
i loved it. so it was my second home and wasa able to talk to people about it, i bragged about it and itold them how great it was and they're all so smart and niceand fun but they really couldn't see it with their own eyes andthen from the perspective of now working in healthcare just downthe road because yes we know that nih is here and it's likethe big important nih if you have an infectious diseasequestion and then you call the cdc, and anything else you callnih, except for infectious
disease, you guys do that greatbut it was a nebulous entity, i think that everyone referred toa lot but no one really knows the ins and outss of whatgoes on here and it was the need to draw the curtain and see thedetails and magic that happens because there's really no way toknow it thls you're walking it and seeing it and living it. >> i think many of us who go tomeetings and talk and how many know there's nih, how many knowthere's a hospital at the nih, the hands go down.
so we as professionals have aresponsibility to get out there and our writer friends go outthere to help us get the word out. so this is an issue. well, thank you all so much forcoming and thank the panelists for an unbelievable group ofpeople and we really appreciate now i have the great honor offirst meeting and now getting to introduce marsha henderson andshe's the assistant administration of food and drugadministration and she leads
women's health and were outreachaties across the agency. marsha's responsibility fordirecting the office of women's health at fda, coordinating fdapolicy, research and outreach efforts to protect and advancewomen's health and advocating for woman's per tisipation inclinical trials, for sex, gender and population analysis, andduring these years at the fda, this served in the developmentof public partnership and cross cutting research teams andculturally preerpt consumer information.
she developed the fda's awardwinning take time to care outreach initiative and built anetwork of national organization to work collaboratively todisseminate fda dissemination, welcome. [ applause ]>> well has this been wonderful, absolutely wonderful. thank you so much. now you know this didn't happenby accident. you know, put together the rightpeople at the right time and the
right place to get you all tocome here today. so i want to start by thankingthe staff that helped in every way putting this together. the panel as you can see hasbeen wonderful because you have truly given a face to clinicaltrials. we've made great strides as itrelates to women being include indeed clinical trials over theyears and the discussion today illustrates that there reallyare women in clinical trials. we often hear women aren'tclinical trials, women are in
clinical trials, as has beensaid, i direct the office of women's health at fda but as ilisten to their stories, i thought about my own. you see i too was in or am in aclinical trial. some years ago, i was diagnosedwith glaucoma and the traditional approach of usingdrops every night didn't work for me. then, i went for a laserprocedure, that didn't work for me.
and i got nervous, you know whenplan a and plan b don't work and you have to go to door numberthree, you start to get a little nervous, so, i went to hopkinsand had a traditional surgical procedure calledtribeculaectomy, and that does seem to have worked for me andafter the surgery my doctor said to me would you like to enter aclinical trial and of course i said i work at fda. of course i'll enter a clinicaltrial! so when on that day, tie becamea face of clinical trial.
so once a year i fill out aquestion and i wear this motion machine and i variety of thingsfill out questions fill out the consent forms and all that andyou know can you learn a lot about your condition when youenter a clinical trial. one of the things i learned wasthat i am officially sedentary. so i'm working on that as l. allof the storyings story--stories we've heard today from the women todaythey that you should and can participate. all the levels of success withthe women in clinical trials
we've not been as successfulwith diversity in women's clinical trials. women of various ethnicity,races, ages, co-morbidity and to achieve this diversity we mustall play a role, the role of patient protection and educationand information, in research in regulatory process, asclinicians and clinical trial participants, everyone has arole. our speakers today showed us thevarious roles that they play from dr. clayton, we learnedthat nih has a specific way of
supporting clinical trialsresearch from the compelling key note resentation of dr. rosalauren wood, we learned about the ps and the cs and to themasterful moderating of laurel lee, the panel discussion alsotold us that it's an interdisciplinary approach,bringing all of the skill sets that we have to thisrecruitment, retention and analysis process. now fda plays a very differentrole, we do not conduct clinical trials although many peoplethink that we do we see our main
role for policies that promotethe adequate inclusion of women, in clinical research and theanalysis of the data to assess sex differences and this is anessential role although different from that of nih andothers we evaluate the trial data submitted to us by aproduct sponsor medical product sponsor and we do that for tworeasons to understand the risk and assure the safety andefficacy of the products. fda has been looking at theinclusion of women's participation for over 20 yearsand while we continue to know
that we need to explore evenfurther, we have made great strides. depending on the years and thedrugs for example that visit been studied. we have made up anywhere from 43to 56% of the participants enroll indeed new drugapplication. there's been improvement also atthe early phases as well. and although there's noconsensus about the criteria that should be used to assessthe adquaisy and level of
participation of women ifclinical trials. i think we can all say thatwe're not where we were 20 years ago. so what's next? my office, the office of women'shealth at fda and the nih office of research on women's healthwill be collaborating on a national campaign to raiseawareness about the importance of participation in clinicaltrials. and of diverse participation inclinical trials.
we will share best practicesrelated to clinical research design, recruitment, retentionand subpopulation analysis. we will conduct educationalresearch in select disease and therapeutic areas and we willconvene scientific dialogues and identify training resources forinvestigators and health professionals. the workshop today is the firstwe hope in the series and i think you all have given us afabulous kickoff. i encourage you all to look atclinicaltrials .gov.
as was stated people often don'tknow about clinical trials. nih is a fabulous place but notmany know of nih. we have a variety of settings inmany, many institutions but there is a location that willlet you know about all of them and that's called clinicaltrials.gov. i encourage to you look at nihand fda web site for additional information and i encourage youto talk with the women in your networks, your social networks,your professional networks. your family networks.
how often do you talk about aclinical trial. i know i don't go to dinner orto the movies and say, you know i am in a clinical trial. and why don't i? the question is not what i havenot been doing, double negative, but why aren't i talking about aclinical trial? they're at all ranges, whetherit's a life saving procedure, a sight-saving procedure or justgeneral background knowledge to set the stage for futureinvestigation, clinical trials
are so important and we have toget the word out. we've got to start talking aboutit, we have to share our everyone in this room has astory. whether you engage in it as aclinician or investigator, a social worker, a patient, we allhave a story and we need to tell those stories. so from this moment on. let's commit to telling ourstories and to continuing the con.
let's engage, engage, engageeveryone we know in the process, all are needed. men for example are needed inthe clinical trials assessment as we determine what works bestfor women and for men in this process. so i thank you all for coming. the panel will be here after weclose and i want to thank all of you again for telling yourstories and just keep telling your stories again and againuntil we can bring more people
into this space that we callclinical research. thank
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