New changes for clinical trials

By Daniel (Randy) McMillan, Ph.D., Grant & Proposal Writer and Research Administration, Assist. Prof. (Adjunct) of Internal Medicine, UT Southwestern

Everyone involved in clinical trials research is aware of the outsized time commitment required for progress. Often, the time from conception, through subject registration, intervention and data collection is measured in years. Time to publication can then add several years, in both NIH funded and non-NIH funded studies. In an analysis of trials funded by the NHLBI, less than 2/3 of the studies have been published 30 months after completion of the trial.

To address these and other relevant issues, the NIH has proposed “Building Better Clinical Trials through Stewardship and Transparency”. Drs. Hudson, Lauer and Collins first provided an overview in a Viewpoint Essay published in JAMA, which highlighted training, applications, registration, IRB and protocol templates. In addition, a concise graphic of the clinical trial journey overlaid with the proposed stewardship reforms is provided in the Extramural Nexus. 

Michael S. Lauer, M.D., Deputy Director for Extramural Research, in an email to the NIH research community (8/11/17), has now outlined and summarized changes adopted that may affect your application for and compliance with NIH funding for research involving human subjects. These changes will only affect you if your proposed research meets the NIH definition of a clinical trial.   For a simple determination, Dr. Lauer proposes the following four questions:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If you answer yes to all four questions, the NIH considers your research a clinical trial and new application forms (FORMS-E) will be required beginning January 25, 2018. Information concerning the new forms package, including a video tour and a high level summary of the changes can be found here.

Please refer to the Clinical Trial Requirements for Grants and Contracts for the specific information that you will need to know.


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