Learn more about the Principles

Washington, D.C., Oct. 31, 2005 - To strengthen the role of U.S. medical schools and teaching hospitals as trusted and reliable sources of research information, the AAMC (Association of American Medical Colleges) today announced new "Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials."

Failures to release results of ineffective clinical trials and reports of potentially dangerous reactions to drugs and medical devices challenge the credibility not only of industry but also of the academic medical centers where industry-sponsored research trials are often performed. Despite various initiatives in recent years 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. The new AAMC principles are intended to apply to all clinical trials conducted in academic medical institutions, regardless of the source of funding for the trial.

"Researchers at academic medical centers should not be party to the release of misleading statements about trial results or to the suppression of outcomes unfavorable to a sponsor," said AAMC President Jordan J. Cohen, M.D. "Academic medical centers must honor the trust of the American public and scrupulously report their research results fully, credibly and accurately. We believe these principles, if widely adopted, will help achieve these goals."

The new principles are the product of a working conference convened by the AAMC in June, in collaboration with the Centers for Education and Research in Therapeutics and the Blue Cross and Blue Shield Association. Participants were charged with drafting a set of comprehensive guidelines that would direct the ethical and operational aspects of data access, analysis, and reporting of clinical research studies. The principles aim to ensure that academic institutions 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.

Under the principles:

• Academic researchers should determine or approve the research plan and all methodologies by which trial data analysis is to be undertaken
• A lead investigator, a steering committee that represents all investigators, and a publication and analysis committee, the majority of which is composed of academic investigators, must be identified in multi-site trials
• The publication and analysis committee (or principal investigator of single site studies), through a qualified expert of its choosing, should have the right to access any data generated during the study that are necessary to ensure the integrity and validity of the study
• Clinical trials should be registered prior to the first participant's enrollment, and a sustainable mechanism for posting all trial results, for example, in an accessible not-for-profit Web repository, should be developed as soon as possible
• Academic researchers must ensure that positive, negative and null study findings are always published, preferably in peer-reviewed journals.

"Blue Cross and Blue Shield Plans share the AAMC's abiding interest in the protection of the integrity of the scientific process and the knowledge that results from the voluntary participation of patients in clinical trials," said Allan Korn, M.D., chief medical officer, Blue Cross and Blue Shield Association. "The steps initiated by AAMC are meaningful, timely and important to all of us, but especially to patients."

The AAMC will promote adoption of the principles by its member medical schools, teaching hospitals, and academic societies, and will circulate them broadly in order to gain their endorsement by industry, the Food and Drug Administration, non-profit sponsors of clinical trials, patient advocacy groups, the American Medical Association, the major medical and surgical professional societies, and ultimately, the entire medical community, since more than 75 percent of industry-sponsored clinical trials are conducted outside of academic medical centers.

A copy of the "Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials," can be found at: www.aamc.org/research/clinicaltrialsreporting/start.htm

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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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