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By: Robert M. Califf, M.D., Commissioner of Food and Drugs

Earlier this month I wrote about the importance of clinical trial transparency and the FDA’s oversight. Today, I’d like to catch up with you about another critical component of FDA’s oversight of clinical studies: our work to harmonize clinical research regulations and to facilitate the development of medical products to benefit public health. 

Modernizing Clinical Research Oversight

Efficient, well-designed clinical research is a critical element of the FDA’s public health mission to help advance development of safe, effective medical products for patients. Well-designed studies and reliable data inform the FDA’s decision-making about a product’s benefits and risks. The agency has taken several steps to advance clinical research and ultimately promote the generation of evidence needed to demonstrate the safety and effectiveness of medical products.

Additionally, we are working to harmonize our human subject protection regulations, where appropriate, with U.S. Department of Health and Human Service (HHS) Common Rule, a set of federal rules that protect people who participate in research. This work serves to make clinical research more efficient while protecting people participating in the research.

Protecting Participant Rights and Facilitating Medical Advances 

In keeping with this harmonization, the FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research. 

The rule provides an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the people participating in the research, and the research includes appropriate safeguards to protect the rights, safety and welfare of participants. 

We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise. This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients. Studies conducted with a waiver or alteration of informed consent under this final rule could result in more treatment and diagnostic options without compromising the rights, safety and welfare of people participating in those studies.  

• The final rule permits an institutional review board (IRB) to waive or alter certain elements of informed consent, or to waive the requirement to obtain informed consent entirely, under limited conditions, for certain FDA-regulated clinical investigations that pose no more than minimal risk to trial participants.
• The rule continues to protect the rights, safety and welfare of research participants and enables minimal risk clinical investigations that may facilitate medical advances and promote public health.

These efforts will promote additional robust clinical research to generate the evidence needed to inform clinical decision making and ultimately enhance treatment and diagnostic options for patients. 

Catch up with you next time.