New Law Expands Requirements for Clinical Trial Registration

First Deadline is December 26, 2007

Congress recently enacted a new law that mandates the expansion of clinical trial registration on ClinicalTrials.gov. For the most part, this federal expansion was already required by the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO).

Specifically, several registration data elements previously listed as optional by ClinicalTrials.gov -- but required by ICMJE since 2005 -- are now required, and a few new ones have been added. The deadline for entering any missing information is December 26, 2007.

In general, this registration requirement applies to clinical trials of products (drugs, biologics, devices, etc.) subject to Food and Drug Administration (FDA) regulation, with certain exceptions (e.g., Phase I drug trials, small feasibility studies on devices, pediatric device postmarketing surveillance).

Registration is generally the responsibility of the Investigational New Drug (IND) or Investigation Device Exemption (IDE) holder - in many cases the trial's industry sponsor or coordinating center. However, when the IND/IDE is held by the local investigator, or the trial is FDA regulated but does not require an IND/IDE, the investigator may be responsible for completing the registration. In any case, investigators are encouraged to consult their clinical trial agreements or contact their sponsors to verify who is responsible for trial registration.

This law also includes requirements for the eventual inclusion of trial results, and sets penalties for noncompliance. Additional information on these topics will be forthcoming.

• Download: Clinicaltrials_req.doc

At this time, more information is available on the following web sites:

• NIH Guide Notice NOT-OD-08-014
  grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html

• ClinicalTrials.gov Protocol Registration System
  prsinfo.clinicaltrials.gov and prsinfo.clinicaltrials.gov/fdaaa.html

• Fact Sheet
  prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf

• Additional guidance is attached and is posted on the IRBMED web site at www.med.umich.edu/irbmed/guidance/clinical_trial_registration.htm

Raymond Hutchinson, MD, Associate Dean, and
Pat Ward, MPA, Director
Research Regulatory Affairs
734-615-4199
 

Detroit Oral Cancer Prevention Project, Continuing Education Course

A full four-hour CE course on oral cancer screening and prevention with a quiz (interactive) is now available online at www.detroitoralcancer.org.

 

Michigan Clinical Research Symposium, Inaugural Symposium 2008

Clinical Research to Clinical Practice: Managing Challenges at the Cutting Edge
Where: University of Michigan, Ann Arbor, Michigan
When: September 11 - 13, 2008 (Thursday - Saturday)

Click here for more information

The mission of the Center for Oral Health Research is to serve the University of Michigan School of Dentistry, the profession, and the public in the translation of basic knowledge into new clinical therapies and the evaluation of existing therapies in contexts in which there are important evidence gaps to improve oral, dental and craniofacial health.

Innovation: We believe that the facilitation of translational research from bench top to the clinic, through collaborations between various multidisciplinary research cores, is the key to innovative treatments that will ultimately improve the oral health of the general public. Service: We will support collaboration and research efforts of all faculty, staff, and student researchers from all disciplines at the School of Dentistry. Education: We will provide training and education for future researchers by pooling the intellectual resources at the School of Dentistry, along with the knowledge and expertise of various biomedical research disciplines at the University of Michigan.

The vision of the Center is to be an internationally recognized center of excellence in oral, dental and craniofacial clinical research and be respected throughout the academic, government and professional communities for its collective contribution.