In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials, including the need to pick clinical trial -specific funding opportunity announcements for due dates of January 25, 2018 and beyond.
We have made no changes to the NIH definition of a clinical trial, or how the definition is interpreted. What we have done is revise existing case studies and add a few new ones to help clarify how the definition of clinical trial does or does not apply to: studies of delivery of standard clinical care, device studies, natural experiments, preliminary studies for study procedures, and studies that are primarily focused on the nature or quality of measurements as opposed to biomedical or behavioral outcomes..
As a reminder, the case studies illustrate how to apply the four questions researchers involved in human studies need to ask, and answer, to determine if their study meets the NIH definition of a clinical trial. These questions are:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is yes, then we consider your research a clinical trial.
Note that If the answers to the 4 questions are yes, your study meets the NIH definition of 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
- Your study is utilizing a behavioral intervention
Studies intended solely to refine measures are not considered clinical trials.
The adjustments to the case studies include the following:
- #7a, #8a, #24, #31a: Clarified whether it meets definition of intervention
- #18c: Replaced with a more illustrative case study
- #18d, 24, and 33: Clarified whether study was designed to assess the nature or quality of a measurement, as opposed to the effect of an intervention on a behavioral or biomedical outcome.
- #18g: New case study about testing procedures
- #36 a-b: New case studies about standard clinical care
- #37: New case study about Phase 1 device studies
- #38: New case study about natural experiments.
- #39: Proposed case study about preliminary tests for study procedures.
- New case studies specific to select NIH Institutes and Centers
We recognize that sometimes in an attempt to be helpful we end up providing a lot of material to look through. So to help you quickly find the case studies that are most relevant to your research we have added the ability to filter the case studies by keyword.
We also added two new FAQs on standard clinical care and Phase 1 devices.
Thank you for your continuing dialog on this topic. We look forward to continuing to work with you as we move towards higher levels of trust and transparency with our clinical trials.
Update: Some of these case studies have been revised since this publication.