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ICMJE updates its requirements for clinical trials registry

Member journals would consider publishing ongoing clinical trials only if registered before Sept. 13.

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The International Committee of Medical Journal Editors has issued a follow-up editorial regarding its goal to foster a comprehensive, publicly available database of clinical trials.

The new editorial, jointly authored by 11 member journals of the International Committee of Medical Journal Editors (ICMJE), updates and clarifies several points made in its earlier joint editorial published in September 2004. The new editorial, published online by the Journal of the American Medical Association in advance of the June 15 print edition, states that the journals would consider publishing clinical trial results only if the trial had been registered before enrollment of the first patient. “This policy applies to trials that start recruiting on or after July 1, 2005. Because many ongoing trials were not registered at inception, we will consider for publication ongoing trials that are registered before Sept. 13, 2005,” the authors said.

Since the ICMJE statement in September, many other journals have joined the effort. The U.S. Congress is also considering legislation. The proposed Fair Access to Clinical Trials Act would expand the current mandate for clinical trial registration. The journal editors are also working with the World Health Organization toward “the goal of a single worldwide standard for the information that trial authors must disclose,” according to a JAMA press release.

The authors of the editorial define a clinical trial as, “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.”

In an update to their 2004 definition, the editors added that “a trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration.” The journals would also require registration of “all trials whose primary purpose is to affect clinical practice (phase 3 trials),” the authors said.

“The registry must be electronically searchable and accessible to the public at no charge. It must be open to all registrations and not for profit. It must have a mechanism to ensure the validity of the registration data,” the authors said.

“The purpose of a clinical trials registry is to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making. We will do what we can to help reach this goal. We urge all parties to register new and ongoing clinical trials,” they added.

For more information:

• DeAngelis CD, Drazen JM, Frizelle FA, et. al. Is this clinical trial fully registered? A statement from the international committee of medical journal editors. JAMA. 2005;23. Accessed online in advance of print, June 1, 2005. Available at: http://jama.ama-assn.org/cgi/reprint/293.23.jed50037v1.