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Financial Conflicts of Interest in Medical Research Karen Santoro Deputy Ethics Counselor National Institute of Allergy and Infectious Diseases.

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Presentation on theme: "Financial Conflicts of Interest in Medical Research Karen Santoro Deputy Ethics Counselor National Institute of Allergy and Infectious Diseases."— Presentation transcript:

1 Financial Conflicts of Interest in Medical Research Karen Santoro Deputy Ethics Counselor National Institute of Allergy and Infectious Diseases

2 Favorable Results Inconclusive Results Negative Results Financial Ties to Sponsor NEJM Vol. 338 (1998) Stelfox

3 NIH Industry 30% 70% NEJM Vol. 342 (2000) Brodenheimer Clinical Research Support

4 Industry Support Of Academic Health Centers

5 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/$25-50MM) Clinical Trials, Phase III (~3.0 year/$ MM) “Genomics and New Technologies as Catalysts for Change in the Drug Discovery Paradigm”) Jeffery Hanke, PhD.

6 1995 Objectivity in Research Regulations  Disclose “significant” interests  Institution discretion

7 Stock Publicly Traded Consulting Fees HonorariaResearch Support NIH- funded > $10,000 > $ 10,000 (for profit) > $ 10,000 FDA > $50,000 > $25,000 > $25,000 OGE > $5000Any Any Personally Held NE AHC > $20,000> $10,000 4 x annually > $10,000

8 Future AAU Report Oct GAO Report Nov AMA Recommendations Jan AAMC Task Force Dec. 2001


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