What is a Clinical Trial?

Posted in: #CC/Academic List, #Health Sciences List

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The Food and Drug Administration Amendments Act (FDAAA) of 2007 clarified requirements for clinical trials including submission to ClinicalTrials.gov. In 2014 NIH required that all NIH funded clinical trials be submitted to ClinicalTrials.gov. At that time it revised the definition of a clinical trial. Since 2014 NIH has written regulations on submitting results to the database.

Within the research community there is again questions about the definition of a clinical trial. To meet the NIH criteria for a clinical trial the answer to all four questions below must be “yes.”

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?

You would think answering these questions would be clear cut. However, there are nuances that can make it not easy. If you are working with researchers you may be pulled into the discussion about whether their research is a clinical trial. This affects what NIH grants they can apply for and of course affects whether or not they are required to submit their study and results to ClinicalTrials.gov. To learn more about what is or isn’t a clinical trial, faqs and case studies,  check out the Open Mike blog. /ch