Volume 9 Issue 155
Published - 14:00 UTC 08:00 EST 4-Jun-2007 
Next Update - 14:00 UTC 08:00 EST 5-Jun-2007

Editor: Susan K. Boyer, RN
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International journal group updates guidelines on registration of clinical trials

(4 June 2007: VIDYYA MEDICAL NEWS SERVICE) -- The International Committee of Medical Journal Editors (ICMJE) updates its policy for registration of clinical trials, in an editorial appearing today on the organization’s Web site (www.icmje.org) and on the Web sites of participating journals.

The update aligns ICMJE policy with the World Health Organization Clinical Trials Platform (WHO ICTRP).

The revised ICMJE policy now says:

In addition to accepting registration in any of the five existing registries, the ICMJE will accept registration of clinical trials in any of the primary registries that participate in the WHO ICTRP. Registration in a partner registry only is insufficient.

The ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrollment on or after July 1, 2008. This definition states that a clinical trial is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”

The ICMJE will not consider results posted in the same clinical trials registry in which the primary registration resides to be previous publication if the results are presented in the form of a brief, structured (<500 words) abstract or table.

The ICMJE editorial will appear simultaneously on (www.icmje.org) , the Web site of Annals of Internal Medicine (www.annals.org) and in a number of other ICMJE journals.

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