Recent amendments to FDA law (Public Law 110-85) expanded the scope of clinical trials that must be registered in ClinicalTrials.gov. In general, all controlled, clinical investigations of a product subject to FDA regulation (except Phase 1 investigations) must be registered. For more information on the new law, including information on which trials need to be registered, who is responsible for registering trials, and how to register, click HERE.
The new law is consistent with policy set forth by the International Committee of Medical Journal Editors (ICJME), which requires clinical trials to be registered in a public trials registry as a condition of consideration for publication. Trials must be registered prior to the commencement of patient enrollment.
"Is This Clinical Trial Fully Registered? A Statement from the International Committee of Medical Journal Editors," an article in the June 15, 2005 (Vol. 293, No. 23) edition of JAMA, describes the registration requirements. Please reference this article and www.clinicaltrials.gov for details about registering a trial.
This article defines a clinical trial for the purposes of registration as, "[a]ny research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. By "medical intervention," [they] mean any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like. [They updated their] 2004 editorial to state that a trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration."
JHSPH has an organizational account with clinicaltrials.gov. If you are a JHSPH principal investigator and need to register your study, please contact the Research Regulations Specialist, at 410-502-0433 or email@example.com.
DeAngelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA. 2005;293:2927-2929.
DeAngelis, CD, Drazen, JM, Frizelle FA, et al. Clinical trials registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004; 292:1363-1364.
NIH Guidance on Public Law 110-85: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
Public Law 110-85 can be found at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110