Funding News - New Rules for Reporting Clinical Trials

The FDA Amendments Act of 2007 (Title VIII) expanded the ClinicalTrials.gov registry to include mandatory reporting of phase II-IV clinical trials of drugs and devices. The law requires timely registration of clinical trials, and subsequent reporting of results.

Clinical trials for serious and life-threatening diseases that were ongoing as of December 26, 2007, should have been registered in ClinicalTrials.gov by December 26, 2007.  All new phase II-IV clinical trials should be registered by September 27, 2008.

Registration of NIH-funded applicable clinical trials in the database have to be certified before funding can be released.  Competing grant applications submitted to the NIH on or after January 25, 2008 that include applicable clinical trials should include information about registration (e.g., the NCT number, the brief title, and the name of the responsible party) of any ongoing trials in the “Human Subjects” section of the research plan.  If a new applicable clinical trial is proposed in the grant, the “Human Subjects” section of the research plan should include a statement that the application includes a trial that requires registration in ClinicalTrials.gov.

All progress reports for grants that include an applicable clinical trial with budget start dates of April 1, 2008 or later should include information about any ongoing trials in the “Human Subjects” section.

The Act states that the information is to be submitted by a "responsible party."  It defines the trial’s responsible party as the sponsor or the principal investigator—if so designated by a sponsor, grantee, contractor, or awardee (provided that "the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements" for submitting information under the law).  NINDS program directors can help with the registration process.

For more information, see NIH Guide Notices http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html.