Washington, D.C., January 17, 2007—The AAMC (Association of American Medical Colleges) and the Blue Cross and Blue Shield Association (BCBSA) announced today that the nation's 39 Blue Cross and Blue Shield companies have formally endorsed the AAMC's Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials.

"The nation's medical schools and teaching hospitals strive to honor the public's trust and maintain the highest integrity in the analysis and reporting of clinical trials," said AAMC President Darrell G. Kirch, M.D. "The support of the Blue Cross and Blue Shield companies for these principles will help us achieve that goal."

"The integrity of the information used by Blue Cross and Blue Shield companies for the purpose of coverage decisions must be unimpeachable," said BCBSA Medical Director Allan Korn, M.D., F.A.C.P. "Lives, not money, hang in the balance. Each Blue Plan has endorsed these principles and will increasingly be looking for contracted hospitals to make a similar commitment. We applaud the leadership of the AAMC."

The AAMC principles were developed in collaboration with BCBSA to strengthen the role of U.S. medical schools and teaching hospitals as trusted and reliable sources of research information. The comprehensive guidelines direct the ethical and operational aspects of data access, analysis, and reporting of clinical research studies. Their goal is to ensure that academic institutions do not accept restrictions by sponsors that would exclude members of academic research teams from full intellectual participation in studies and thereby prevent those investigators from being held responsible and accountable for the results.

The principles are intended to apply to all clinical trials conducted in academic medical institutions, regardless of the source of funding for the trial. They include recommendations on publication, authorship and public availability of research results; the registration of clinical trials; and the need to identify a lead investigator, steering committee, and a publication and analysis committee.

Failures to release results of ineffective clinical trials and reports of potentially dangerous reactions to drugs and medical devices would challenge the credibility not only of industry but also of the academic medical centers where industry-sponsored research trials are often performed. While initiatives in recent years have highlighted the need to heighten standards for reporting trial results, published studies indicate that practices for analyzing and reporting the results of sponsored clinical trials in the academic medical community vary widely and/or are enforced variably.

Read the Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials

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The Association of American Medical Colleges is a not-for-profit association representing all 129 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 68 Department of Veterans Affairs medical centers; and 94 academic and scientific societies. Through these institutions and organizations, the AAMC represents 109,000 faculty members, 67,000 medical students, and 104,000 resident physicians. Additional information about the AAMC and U.S. medical schools and teaching hospitals is available at www.aamc.org/newsroom.

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