How To Create A Veteran Prgram
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- Bertram Newton
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1 Millin Veteran Prgram Part I: Develpment & Use f Database Jel Kupersmith, MD Chief Research & Develpment Officer
2 Millin Veteran Prgram The Millin Veteran Prgram will create a genmic database ver 5-7 years f 1 millin Veterans wh are users f the VA healthcare system Database will have available DNA specimens and links t tissue specimens Access t the VA Electrnic Health Recrd IT capability t identify patients fr a variety f types f studies Analytical tls MVP is part f a larger initiative in genmic medicine by the VA 2
3 Millin Veteran Prgram MVP will facilitate Develping new diagnstic tests t enable disease preventin and earlier treatment Persnalize therapies t the Veteran's individual genetic characteristics and cnditins, e.g. Pharmacgenmic custmizatin Cnduct surveillance fr early detectin f military expsure and ther deplyment-related cnditins and pssibly link them t genetic susceptibilities Overall establish hw genetic infrmatin will be used in clinical medicine Link gentype t phentype Cmplex, adult, multi-gene diseases pssibly with strng envirnmental influences VA assets Large HCS, Electrnic Health Recrd, research embedded in clinical prgram Large ppulatin with substantial diversity Enables rigrus examinatin f a variety f subppulatins 3
4 MVP/Genmic Medicine Initiative: Building Infrastructure Genmic Medicine Prgram Advisry Cmmittee (GMPAC) Birepsitry (in Bstn) t extract and stre DNA frm samples - Expanding t 4 millin samples Special labratries and cntracts, e.g. Pharmacgenmics Equipment purchases Central IRB IT infrastructure t enable research use f databases High perfrmance envirnment and secure platfrm fr string and analyzing genetic and health infrmatin Crdinate central recruitment, scheduling and enrllment fr studies using MVP database Sftware analysis and reprting tls fr all prjects Natural language prcessing Veterans Cnsultatin Prject Survey
5 Genmics Survey Findings With VSO and Veterans cllabratin, internet survey perfrmed April 24 May 5, 2008 N = % said prgram shuld be dne Increased supprt assciated with Attitudes abut research Attitudes abut helping and histry f previus altruistic behavirs Curisity abut genetics Satisfactin with VA healthcare Imprtant issues Privacy Safeguarding data
6 Millin Veteran Prgram Enrllment Prcess Receive letter f invitatin t MVP Respnd t the letter Read and sign an infrmed cnsent and HIPAA authrizatin in VAMC Fill ut health and behavir surveys Prvide cntact inf Prvide a bld sample Get an ptinal health assessment Allw secure access t VA and VA-linked medical and health infrmatin
7 Prtectin f Veteran s Samples and Data Security Veteran s samples and health data will be labeled with a cde instead f the name r ther persnally identifying infrmatin Samples will be stred in a central, secure birepsitry and data will be stred in a central, secure database All analyses will be perfrmed behind a secure firewall VA Central Institutinal Review Bard review Initial and nging review f all aspects f MVP study design, implementatin, and peratin Access t data and samples fr any database prject will be granted nly after rigrus scientific peer review and specific new IRB apprval
8 Research Using MVP Database
9 Research Using MVP Database Identificatin and validatin f genmic assciatins Genmic custmizatin f treatment bservatinal studies t be validated by clinical trials (including trials cnducted by the VA Cperative Studies Prgram) Ppulatin surveillance (illnesses fllwing deplyment, fr example) Studies validating the effectiveness f using genmic data in the healthcare system
10 Validating Use f Genmic Data in Healthcare
11 Using MVP Database Research Appraches t Validatin Observatinal Studies Retrspective and prspective database analysis Natural experiment but cnfunding factrs and bias are issues Stratificatin, Regressin analysis, Case cntrl, Matching, Prpensity scres, Instrumental variables, etc Randmized Clinical Trials Trials perfrmed under strict labratry cnditins Cnfunding factrs addressed by randmizatin Rigrus but limits in generalizability and applicability f RCT prtcls and issue f expense and time Pint f Care Research Hybrid being pilted in VA Natural experiment with randmizatin Hw VA can cntribute t general research capability
12 Pint f Care Research Research designed t randmize clinical chices within the healthcare system at Pint f Care Chices that are part f care but have equipise At Pint f Care, when a patient identified by MVP sftware sees clinician, EHR reminder will infrm that patient is a suitable research subject Clinician in rutine visit decides whether the patient s identified shuld be randmized and, if s, enters the patient int the study Randmized study is then cnducted by the patient s clinician within the healthcare system using healthcare system resurces and with findings recrded in patient s EHR
13 Pint f Care Research Examining Use f Genmic Data Pint f Care Research examining use f genmic data Hypthetical example - Decisin-making via genetic testing when initiating Warfarin therapy Arms f study might be Hspital labratry initiatin and mnitring fllw-up with clinician-determined dsing Hspital labratry initiatin fllwed by hme PT mnitring with clinician-determined dsing Hspital labratry initiatin with clinician-determined dsing fllwed by hspital lab mnitring with cmputer-assisted dsing Hspital labratry initiatin fllwed by hme PT mnitring with cmputer-assisted dsing Initial dsing using genetic testing, fllwed by any f abve Direct healthcare system data btained
14 Millin Veteran Prgram Part II: Questins fr Discussin Timthy O Leary, MD, PhD Deputy Chief Research & Develpment Officer
15 Issues t Cnsider Technical issues with regards t specimen handling and analysis Issues assciated with data sharing Return f research results t Veterans Implicatins fr health care systems
16 Specimen Handling and Analysis The cst f whle genme sequencing is drpping rapidly. Shuld VA make sequencing the standard fr analysis? Level f cverage? (80%, 90%, mre?) Depth f sequencing (40X, 200X?) Cst vs. value? Begin nw r wait fr lwer csts and increased reliability? Hw shuld VA apprach the issues f prviding specimens t researchers, r instead the resulting data?
17 Data Sharing Hw can VA make data frm MVP widely available t the cmmunity while prtecting Veterans?
18 Re-identificatin Risk What risks f re-identificatin must be mitigated t prvide individualized genmic infrmatin and/r health recrd infrmatin t the research cmmunity?
19 Return f Results Shuld VA develp a strategy that wuld allw return f individualized results t Veterans?
20 Implicatins fr Health Care Systems Hw can health care systems prepare t deal with a pssible deluge f infrmatin?
21 Cnclusins The Millin Veteran Prgram will create a substantial database f genmic and healthcare data Research deriving frm this database at all levels f study will address issues fr the benefit f Veterans and all Americans VA has the apprpriate assets, has created an infrastructure and has established a lgistical structure t accmplish these ends Database enrllment is prceeding well
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