diabetes clinical and translational research: rewards and challenges ruth s. weinstock md phd...
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Diabetes Clinical and Translational Research:Rewards and Challenges
Ruth S. Weinstock MD PhDMedical Director, Joslin Diabetes Center and Clinical
Research Unit Professor of Medicine and Chief, Endocrinology, Diabetes
and MetabolismSUNY Upstate Medical University
Syracuse NY
October 24, 2011
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Disclosures
Research funding: NIH/NIDDK, Helmsley Charitable Trust
Speaker bureaus/honoraria: none
Multicenter clinical trials:
Diamyd, Eli Lilly, Pfizer, Ultradian Diagnostics Inc., GlaxoSmithKline, Macrogenics, MiniMed
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Prevention and Management of Diabetes:Types of Clinical Research
• Initiation:– Investigator vs. non investigator
• Focus:– Medications – Devices– Behavioral interventions – Epidemiology– Quality of life– Health services– Others
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Sponsors
Federal: NIH, DOD, VA, CMS, otherFoundations/non-for-profits (ADA, JDRF, others)State health departments (usually limited funding and indirect
cost recovery)Industry:
Phase I: evaluate safety, determine dose, side effects (n=20-80)Phase II: evaluate effectiveness, further safety (n=100-300)Phase III: confirm effectiveness, monitor side effects, compare to standard Rx (n=1000-3000)Phase IV: collect more information re: risks, benefits, uses
Hybrids
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Why Participate?
• Intellectual benefits: contribute to understanding of disease and development of new therapies
• Academic rewards
• Early experience with new treatments
• Free services/medications to the needy
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Requirements
• Trained staff• For subjects: benefits > risks• Adherence to GCP (Good Clinical Practice) principles• Compliance with federal regulations (Protection of Human
Subjects)• IRB approval• Ability to meet recruitment and retention goals• Meticulous record keeping• Sufficient funding (careful budgeting!)• Dependent upon study: EMR, statistical/study design support,
specific facilities eg Clinical Research Unit• Must follow protocol exactly!
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Considerations for Participate in Clinical Trials
• Do you have the required?– Patient population– Collaborators– Ancillary services– Equipment– Facilities (e.g. inpatient vs outpatient, pantry,
pharmacy, laboratory, specimen processing)– Trained, dedicated staff– Time (P.I. etc)– Other
• Is budget sufficient?• Duration of study?
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Current Diabetes Grants at Upstate Medical University
NIH (n=6)
Industry-sponsored multicenter clinical trials (n=13)
Foundation (Type 1 Diabetes Exchange)
NYS Dept of Health Diabetes Center of Excellence (support community outreach, professional education and pilot projects e.g. school telemedicine)
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Upstate Clinical Diabetes NIH Grants
Investigator-initiated: SHINE, DSPSupport salaries (% effort), other costsHighest indirect cost recoveryMost difficult to obtainGreatest intellectual/academic gratification
SBIR (Small Business Innovation Research)Partner with small business (new CGMS device)Joint federal and industry sponsorship
Multicenter trials: TODAY, TrialNetFunding: traditional (% effort) or accrual based
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Diabetes Industry-Sponsored Multicenter Clinical Trials
• Usually little input from investigators re: design• Competitive enrollment• Funding: based on recruitment and retention• Indirect cost recovery: 30—50% of NIH• Need to meet enrollment and retention goals• May be discontinued at any time• Need significant number of subjects to break
even
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So…Should We Participate?
Carefully consider all factors (budget, patient population, staffing, other support) before committing
Once committed, need to perform to expectations
ENJOY!
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THANK YOU!