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COMPARATIVE EFFECTIVENESS RESEARCH IN THE
VA COOPERATIVE STUDIES PROGRAM
Grant D. Huang, MPH, PhD
30 Years of Comparative Effectiveness Research Conference
Washington, DCSeptember 23, 2009
OUTLINE
• Cooperative Studies Program (CSP): A national clinical research infrastructure
• CSP study development process
• Lessons from CSP comparative effectiveness research efforts
CSP OVERVIEW
• CSP is a national infrastructure for sponsoring, developing & executing: Multi-site clinical trials Epidemiological & population research Genomic medicine research
• First Cooperative Study conducted in 1940s on streptomycin for treating tuberculosis in WWII veterans Program formally established in 1972
• Over 175 clinical trials and observational studies completed including landmark studies in cardiovascular disease / cardiovascular surgery, infectious diseases, surgery, gastroenterology, mental health, oncology, and endocrinology
CSP COMPARATIVE EFFECTIVENESS RESEARCH
• CSP #494 – Prolonged exposure therapy vs. patient-centered therapy for Post-Traumatic Stress Disorder in women Journal of the American Medical Association, Feb 28, 2007
• CSP #424 (COURAGE) – Percutaneous coronary intervention/optimal medical therapy vs optimal medical therapy alone New England Journal of Medicine, March 27, 2007
• CSP #530 – Intensive vs less intensive renal replacement therapy for acute kidney injury New England Journal of Medicine, May 20, 2008
• CSP #468 – Deep brain stimulation vs. best medical therapy for improving motor symptoms in Parkinson’s Disease patients Journal of the American Medical Association, January 7, 2009
On-going / planned studies address areas of:- Stroke rehabilitation, rheumatoid arthritis, diabetes, cardiovascular
surgery, prostate cancer, depression, low back pain
CSP RESOURCES & EXPERTISE
• CSP is comprised of: 5 data/statistical coordinating centers 4 epidemiological research centers 1 clinical research pharmacy coordinating center 1 health economics resource center Pharmacogenomics analysis lab; DNA/tissue repository
• Center expertise includes: Biostatistical / epidemiological expertise Clinical expertise Safety and regulatory oversight Health economics expertise Pharmaceutical management Clinical research project & fiscal management Genomics Informatics
• CSP studies go through VA Central IRB
CSP RESEARCH
• VA clinician-investigators partner with CSP experts to develop and conduct national studies of high clinical relevance
• Close integration with patient care provides an environment for both identifying key clinical questions and an ability to execute studies 82 VA medical centers involved in FY09 VA sites/study: 4 to 43; Average # of VAMCs/study = 17
• CSP & VA network provides strong experience base for continual generation of CER-related inquiries Investigators interact in multiple scientific & clinical forums Tradition of CER-based inquiry passed on to other VA investigators
COOPERATIVE STUDIES PROGRAM SCIENTIFIC REVIEW PROCESS
Medical Center
Local VA Research
Office
External Review
External Review
Study Proponent
CSRD Director
approval for planning
CSRD Director
Decision / approval
Study planning meetings (2+)
Cooperative Studies Scientific Evaluation Committee Review
Study ProponentClinical & Biostatistical
reviewers
Study team+
Central Office
Admini-
strative
Review External Review
CSP Central Office
CSP Coordinating
Centers
VAMC
VAMC
VAMC
VAMC
Study sites
Planning Committee
CSP Coordinating
Center(s)
Study Proponent
Clinical Experts
Score & Comments
Score & Recommendation
Letter of Intent
Research Proposal
STUDY INITIATION
• Study ideas are generated from VA clinician-investigators based on: observations from clinical practice; efforts to address gaps in the literature; priorities identified at scientific conferences and/or among the clinical
community; research needs expressed by VHA Patient Care Services leaders; responses to Office of Research & Development solicitations or service
directed projects.
• Study proponents include VA national program directors, VA and NIH research center directors, VA clinical chiefs, and other leading clinical experts
• Multiple treatment options available to practicing clinicians help lead to questions involving head-to-head comparisons of treatments and/or strategies.
• Intensive planning process helps to refine the clinical question and methodological approach for definitively answering it. VA Central Office is involved from early stages in study development
• All studies focus on enhancing care to Veterans
SCIENTIFIC REVIEW
• Clinical relevance To Veteran population To general public Timeliness
• Methodology• Feasibility
Testable hypothesis Sample size
• Ethical considerations• Resources needed• Investigator qualifications
Will the study change clinical practice?
Face-to-face review with a diverse group of clinicians and biostatisticians/epidemiologists plays a critical role in
study approval.
CSP MISSION
To advance the health and care of Veterans through collaborative research studies that produce innovative and effective solutions to national healthcare problems.
TEAM EFFORT
ALL are key to the success of the study
Study TeamStudy Team
StudyStudy DevelopmentDevelopment
Organizational Organizational & Start-up& Start-up
ExecutionExecution
EnrollmentEnrollment -- -- Follow-upFollow-up
Analyses & Analyses & Close-outClose-out
Study Chair
Biostatistician
Research Pharmacist
Health Economist
Project Manager
Site investigators
Nurse/Site Coordinators
Programmers
Executive Committee
Scientific / Scientific / EthicalEthicalreviewreview
Scientific Scientific peerpeer
reviewreview
Scientific / Scientific / EthicalEthicalreviewreview
IRB / R&D
FDA
Human Rts Cmte
IRB / R&D Cmte
FDA
Human Rts Cmte
Data Monitoring Cmte
COLLABORATORS
• National Institutes of Health NIDA, NIDDK, NINDS, NCI, NHLBI, NIMH, NIDCD
• Department of Defense• Universities• Industry• International
Canadian Institutes of Health Research United Kingdom Medical Research Council
SUMMARY & LESSONS
• Stable clinical research infrastructure enables the establishment of expertise that focus on developing and conducting high impact clinical studies.
• Integration of clinical and methodological researchers within a health care system provides a strong environment for continual development of CER
• Rigorous planning and review process leads to critical refinement of a study question that seeks to change practice. Contributions from a diverse group of clinicians, biostatisticians,
epidemiologists, and leadership enhance overall research product.
• Culture of collaboration and commitment to a common mission are key to all efforts. Shared desire to improve Veteran and national health plays a central role in
program activities.
ACKNOWLEDGEMENTS
Thanks to all of the of Veterans who have participated in CSP studies.
QUESTIONS?QUESTIONS?
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