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?

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: