The latest update from the International Committee of Medical Journal Editors on regulations for clinical trials mandates the registration of phase I clinical trials. The article includes these key summary points:

-In addition to accepting registration in any of the 5 existing registries, the ICMJE will accept registration of clinical trials in any of the primary registers that participate in the WHO ICTRP. Registration in a partner register only is insufficient.

-The ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrollment on or after 1 July 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 (less than 500 words) abstract or table.

This article follows the original Sept 2004 ICMJE announcement on clinical trial registration and the subsequent updates in October 2004 and May 2005.

ICMJE’s 2004 announcement sparked much controversy, and debate has been ongoing since. While many researchers have argued that phase I clinical trial registration will stem progress by stifling competition, organizations such as the World Health Organization and the Council of Science Editors have favored ICMJE’s decision. ICMJE claims that phase I clinical trial registration is necessary to counter the bias in trial reporting, which has often favored positive trials over negative or ambiguous trials.