The Pharmaceutical Industry and International Clinical Research: One Company’s Approach

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The Pharmaceutical Industry and International
Clinical ResearchOne Companys Approach

• Michael Clayman, M.D.
• Vice President, Lilly Research Laboratories
• Eli Lilly and Company

OIA Speaker Series May 5, 2006
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Background

• Lilly conducts corporate-sponsored clinical
  research in 17 countries
• Including India and China
• With the exception of South Africa, not in Africa
• Conduct of clinical trials in developing
  countries considered by Lilly Bioethics Committee
  (BEC) over several months
• BEC R and D leaders (medical, regulatory,
  legal) Bob Levine and Tom Beauchamp
• Consultation with Eric Meslin

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Conduct of International Clinical Trials BEC
Position Statement

• Lilly applies a single baseline global standard
  to the conduct of clinical trials. Specifically,
  Lilly conducts all trials in accordance with the
  ethical principles that have their origin in the
  Declaration of Helsinki and that are consistent
  with Good Clinical Practices and applicable laws
  and regulations of the country or countries where
  the study is being conducted.

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Conduct of International Clinical Trials BEC
Position Statement

• Lilly is a global company serving the medical
  needs of a global population. In choosing
  locations throughout the world to conduct
  clinical trials, Lilly is guided by the local
  prevalence of the burden of disease under study
  and the medical research capabilities of the
  candidate institutions.

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Conduct of International Clinical Trials BEC
Position Statement

• In addition, Lilly works in consultation with
  local ethics committees and/or health
  authorities, as appropriate, to ensure that
  conducting the proposed research in each location
  is scientifically and ethically justified, taking
  into consideration the following
• the risks and benefits for research participants,
  
• the potential for the research to yield important
  scientific advances,
• the relevance of the research to local health
  needs and priorities, and
• the availability of the intervention under study
  to research participants and/or the community.

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Conduct of International Clinical Trials BEC
Position Statement

• In applying these considerations, Lilly places
  paramount importance on the safety and well-being
  of the individual research participants.