New England Journal of Medicine
August 30, 2012  Vol. 367 No. 9
http://content.nejm.org/current.shtml

Editorial
Transparency for Clinical Trials — The TEST Act
Jeffrey M. Drazen, M.D.
N Engl J Med 2012; 367:863-864August 30, 2012

Extract
In the past few years, registration of clinical trials in a publicly accessible database has become routine. In the United States, much of the impetus for registration derives from the Food and Drug Administration Amendments Act of 2007 (FDAAA). As a result of this law and other actions,1,2 most interventional clinical trials conducted in the United States have been registered at ClinicalTrials.gov, where, in most cases, the trial results must also be reported. The curators of the database have designed a simple tabular format in which the characteristics of the participants enrolled are reported in one table, the key primary and secondary outcomes in a second table, and adverse events in a third table. Journals adhering to the International Committee of Medical Journal Editors guidance for manuscripts submitted to biomedical journals3 have made it clear that reporting results in this fashion will not be considered prepublication of submitted manuscripts.4 One of the purposes of trial registration is to provide a third-party storehouse of trial designs and results. However, for this resource to be of value, it is important that the entire portfolio of clinical trials be in the database.

But there are loopholes in FDAAA that have made it possible for some entities to conduct clinical trials without registering them or reporting the results…