Financial Conflicts of Interest in Medical Research - PowerPoint PPT Presentation

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Financial Conflicts of Interest in Medical Research

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

  4. Industry Support Of Academic Health Centers

  5. “Genomics and New Technologies as Catalysts for Change in the Drug Discovery Paradigm”) Jeffery Hanke, PhD. 100 Discovery Approaches Preclinical Testing (~4yr/$2-5MM Investigational New Drug Application Clinical Trials, Phase I (~1.0 year/$5-10MM) Clinical Trials, Phase II (~2.0 year/$25-50MM) Clinical Trials, Phase III (~3.0 year/$250-500MM) New Drug Application (~2.5 years) 1 Approval Figure 1. The procedure for gaining FDA approval of a pharmaceutical product based on internal benchmarks

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

  7. Future • AAU Report Oct. 2001 • GAO Report Nov. 2001 • AAMC Task Force Dec. 2001 • AMA Recommendations Jan. 2002