Clinical Trial Registration Update

Update: A Dec 21, 2007 NIH Notice provides guidance on complying with the newly passed Public Law 110-85 (also known as the FDA Amendments Act).

NEJM has published a joint review and update of the ICMJE clinical trial registration policy, the most important message of which is the expansion of the definition of a clinical trial (requiring registration): “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.”

So who the heck edits a submission by the editors in chief of 15 major biomedical journals?


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