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

Michael Clayman, M.D. Vice President, Lilly Research Laboratories Eli Lilly and Company. The Pharmaceutical Industry and International Clinical Research: One Company’s Approach. OIA Speaker Series May 5, 2006. Background. Lilly conducts corporate-sponsored clinical research in 17 countries

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

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  1. Michael Clayman, M.D. Vice President, Lilly Research Laboratories Eli Lilly and Company The Pharmaceutical Industry and International Clinical Research:One Company’s Approach OIA Speaker Series May 5, 2006

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

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