Medical Journals Announce New Policy on Trials

New requirements for publishing the results of clinical trials were announced in an editorial published in a number of medical journals, including the September 8, 2004 online issue of The Journal of the American Medical Association (JAMA).

The editorial described new policy guidelines proposed by the International Committee of Medical Journal Editors (ICMJE). Members include the editors of JAMA, The Lancet, The Medical Journal of Australia, The New England Journal of Medicine, The Journal of the Danish Medical Association, The Annals of Internal Medicine, The New Zealand Medical Journal, and Norwegian Medical Journal.

According to the new requirements, registration in a public trials registry is a condition for publication. Trials must be registered at or before the onset of patient enrollment. This policy applies to any trial starting enrollment after July 1, 2005. For trials that began enrollment prior to that date, registration must be made by September 13, 2005.

The registry must be accessible to the public at no charge, must be open to all prospective registrants, and must be managed by a not-for-profit organization. There must be a mechanism to ensure validity of the registration data, and the registry should be electronically searchable. At present, the only registry that meets these requirements is www.clinicaltrials.gov, sponsored by the U.S. government.

These new requirements were no doubt inspired by the recent disclosure that some drug companies may have suppressed or not revealed certain negative trial data. As a result of these disclosures, both the U.S. Congress and Senate are working on new legislation designed to remedy the situation, including a bill that would penalize drug companies that do not comply.

¡°When research sponsors or investigators conceal the presence of selected trials, these studies cannot influence the thinking of patients, clinicians, other researchers, and experts who write practice guidelines or decide on insurance-policy data,¡± wrote the journal editors. ¡°If all trials are registered in a public repository at their inception, every trial¡¯s existence is part of the public record.¡±




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