April 28, 2008 Dear Colleagues: In September, 2007 the FDA Amendments Act became law. As part of the administrative changes associate with this Act, a new policy on trial registration was released on December 21, 2007. As of January 25, 2008 the following new or ongoing trials need to be registered on http://clinicaltrials.gov/: - Trials of Drugs/Biologics: controlled, clinical investigations, other than Phase I, of a product subject to FDA regulations
- Trials of Devices: controlled trials with health outcomes, other than small feasibility studies, and pediatric post market surveillance.
- For trials that are already registered new data fields must be completed.
Of note, there is now the possibility of civil monetary penalties and or withholding of NIH funds for failure to register a clinical trial or submitting of false or misleading information. For additional information on the FDA changes, the best source is http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html. This website also helps an investigator determine who is responsible for registering the trials. In commercial trials, the party responsible for registration will ordinarily be the sponsor. PIs should not register a commercial trial without checking with the sponsor, since dual registrations with inconsistent information can lead to problems and possibly liability for inaccurate registration. PIs who are the investigator/sponsor for an IND or IDE application must register their trials and keep the registration up-to-date. In general, the clinicaltrials.gov website is becoming a very valuable tool for indexing and tracking clinical research. Currently there are over 40,000 studies registered on the site. It is anticipated that in the near future there will also be requirements for reporting summary results. In the meantime I would encourage you to update the information about your study on the http://clinicaltrials.gov/ site every 6 months. I want to alert you to another change in policy as well. The International Committee of Medical Journal Editors (ICMJE) released their first policy on registration of clinical trials in 2005. They have now followed with a second policy that broadens the definition of clinical trials to include preliminary studies or phase I studies (Clinical Trial Registration JAMA 298; 93-4, 2007). The ICMJE have adopted the WHO’s definition of clinical trial: “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.” Health outcomes include any biomedical or health-related measures including pharmacokinetic measures and adverse events. This policy applies to all trials that begin enrollment on or after July 1, 2008. At this time there is no requirement to register any observational study. If you have any doubt about whether a clinical trial needs to be registered, the best approach is to determine who is responsible for the registration and have the study registered. Sincerely, Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation |
