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Financial Conflicts of Interest in
Medical Research
Karen SantoroDeputy Ethics CounselorNational Institute of Allergy and Infectious Diseases
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0
20
40
60
80
100 Favorable Results
Inconclusive Results
Negative Results
Financial Ties to Sponsor
NEJM Vol. 338 (1998) Stelfox
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NIH
Industry
30%
70%
NEJM Vol. 342 (2000) Brodenheimer
Clinical Research Support
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Industry SupportOf
Academic Health Centers
80%
40%
0102030405060708090
100
1991 1998
199180
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Preclinical Testing
(~4yr/$2-5MM
Investigational New Drug Application
Clinical Trials, Phase I
(~1.0 year/$5-10MM)
New Drug Application
(~2.5 years)
1 Approval
100 Discovery Approaches
Figure 1. The procedure for gaining FDA approval of a pharmaceutical product based on internal benchmarks
Clinical Trials, Phase II
(~2.0 year/$25-50MM)
Clinical Trials, Phase III
(~3.0 year/$250-500MM)
“Genomics and New Technologies as Catalysts for Change in the Drug Discovery Paradigm”) Jeffery Hanke, PhD.
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1995
Objectivity in Research Regulations
Disclose “significant” interests
Institution discretion
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StockPublicly Traded
Consulting Fees
Honoraria Research Support
NIH-funded
> $10,000 > $ 10,000
> $ 10,000 (for
profit) > $ 10,000
FDA > $50,000 > $25,000 > $25,000
> $25,000
OGE > $5000 Any Any Any Personally Held
NE AHC > $20,000 > $10,000
> $10,000
4 x annually
> $10,000
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Future
• AAU Report Oct. 2001
• GAO Report Nov. 2001
• AMA Recommendations Jan. 2002
• AAMC Task Force Dec. 2001