AAMC Reporter: November 2005

AAMC Executive Council Adopts Principles for Integrity in Clinical Trials

By Gina Shaw, Special to the Reporter

In the face of heightened public concern over ethical issues involving clinical trials, the AAMC's Executive Council has approved a broad set of principles aimed at protecting the integrity of the conduct and reporting of such trials.

Adopted Sept. 15, the principles include these points:

• Researchers and institutions conducting research involving human beings have an obligation to make the results publicly available.
• All clinical trials should be registered before anyone is enrolled in them, based on recently adopted requirements of the International Committee of Medical Journal Editors (ICMJE) aimed at creating more transparency in the trial process.
• The roles and financial interests of each investigator involved in a clinical study should be fully disclosed.
• All multi-site trials should be overseen by a publication-and-analysis committee made up primarily of academic representatives.
• All trials should make results publicly available within 18 months of the submission of a manuscript for publication, preferably in a results repository and preferably by means of a link to a publication. They should also indicate whether the publication is peer reviewed.

The principles were developed at an AAMC invitational conference attended by nearly two dozen leaders in academic medicine and representatives of other key stakeholder groups. See full text of the principles.

'Clear Guidance'

AAMC President Jordan J. Cohen, M.D., called the document "an attempt to provide the community with some clear guidance about the overarching principles that need to be adhered to, in order to ensure the integrity of research and reporting of the results." He pointed to "very disturbing examples reported in the press about compromises in the principles of prompt and accurate reporting of research results that appear to have been the consequence of conflicts of interest in relationships with industry sponsors of clinical trials and other forms of clinical research."

New questions about the integrity of the research process have been prompted, for example, by reports of surgeons with financial interests in medical devices they implanted in patients, and by controversies over Cox-II inhibitors and the use of antidepressants for children. One participant at the AAMC conference, Robert R. Rich, M.D., senior vice president and dean of the University of Alabama School of Medicine, called the principles document "an important step forward."

"Although there has been general buy-in for some time with respect to the importance of registering clinical trials," he said, "the important new notion that came from this conference is the equal importance of also making the results publicly available — and making sure that those results are analyzed by a committee of which the majority are academic investigators. The analysis of clinical trials should not be principally driven by industry interests, but rather should be driven by the data."

Members of the panel included representatives of the National Institutes of Health and the Food and Drug Administration, as well as academic medical centers. It was co-convened by the Centers for Education and Research on Therapeutics and the BlueCross BlueShield Association. Gail Cassell, vice president for scientific affairs and distinguished research scholar for infectious diseases at Eli Lilly was invited to provide an industry perspective.

"The intent and the need is to engage the pharmaceutical industry, and other partners in the clinical research enterprise, in a dialogue that we hope will lead to a mutual endorsement of these principles," Cohen remarked. "But we believe it was important for the academic medical community to have the opportunity to first put its own ideas forward in a consensus statement as to what it felt was critically important to the integrity of the scientific enterprise."

Rich expressed optimism about the prospect for industry support. "I'm hoping that industry will see that it's not only in the public interest but also in the industry's best long-term interest to support these principles," he said. "I think it should be a cooperative venture between academia and industry to make sure that drugs come to market in an appropriate way — and that the results of clinical trials, either positive or negative, are fully disclosed."

The association is now seeking wide endorsement of the principles document, both within AAMC and more broadly among leading medical specialty organizations, including the American Medical Association, the American College of Surgeons, the American Academy of Pediatrics, and the American College of Physicians.

"We now have what we believe to be a very strong set of principles," said David Korn, M.D., senior vice president of the AAMC's Division of Biomedical and Health Sciences Research. "If they are broadly embraced, it would do a lot to protect and preserve the public trust in clinical trials."

"We would really like to get the community to come together around these principles," Korn added.

A broad endorsement of the document is critical, said another panel member, Harry B. Greenberg, M.D., senior associate dean for research and acting co-chairman, Department of Medicine and Microbiology and Immunology at Stanford University School of Medicine.

"It's essential now to involve more stakeholders and get some level of buy-in so that these principles have some teeth," he said. "The only way we can get somewhere with these principles is if there's agreement among a broad array of academic medical centers that they will abide by them, and that they won't sign research contracts that don't adhere to the principles articulated." Ultimately, Cohen said, such principles are part of the academic medical community's essential obligation to the public. "It's our responsibility to make sure that what we do on their behalf adheres to the highest scientific standards. These are principles that stem from a commitment to those standards, and to public accountability, for the accuracy and integrity of the scientific enterprise."

The association is now seeking wide endorsement of the principles document, both within AAMC and more broadly among medical specialty organizations.

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