Does Your Project Include a Clinical Trial?

Recently, the NIH has begun actively educating investigators and small businesses participating in the SBIR/STTR program NIH Clinical trials. Starting in January 2018, applications proposing clinical trials will only be allowed in response to specific solicitations that permit clinical trials.

Funding Opportunity Announcements (FOA) will now indicate one of three scenarios:

  1. Clinical Trials not allowed;
  2. Clinical Trials optional; or,
  3. Clinical Trials required.

In order to make sure you are responding to the correct FOA, you must first determine if your proposed SBIR/STTR project meets the definition of a clinical trial. NIH clarified this definition in 2016 and provides extensive tools, case studies and a decision tree to help you determine if your planned project meets the definition of a clinical trial. Here are the 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 being evaluated a health-related biomedical or behavioral outcome?

In order to meet the definition of a clinical trial, you must answer YES to all four questions. If you answer NO to any one of the four questions, it is not a clinical trial. If you answer YES to all questions, it is a clinical trial—even if:

  • You are studying healthy participants;
  • Your study does not have a comparison group (e.g., placebo or control);
  • Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug; and,
  • Your study is utilizing a behavioral intervention.

A few other points—studies intended solely to refine measures are not considered clinical trials and studies that involve secondary research with biological specimens or health information are not clinical trials.

Bottom line: While NIH’s tools provide clarity in determining if a proposed project is a clinical trial or not, there is still much gray area. If you have any questions about a project’s classification as a clinical trial, contact the program manager for guidance.


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