Clinical Trials Update: Enforcement of BESH Postponed until 2021
July 25, 2019
On Wednesday, July 24, the National Institutes of Health (NIH) announced that it would delay the enforcement of registering and reporting results of Basic Experimental Studies involving Humans (BESH) on ClinicalTrials.gov to September 24, 2021. This has already been delayed once before.
This decision, published in a Guide Notice (NOT-OD-19-126), reflects NIH’s need for additional time to address current challenges. In an Open Mike blog post, OBSSR Director William Riley and Associate Director for Science Policy, Carrie Wolinetz, indicated NIH’s plans to continue to work with the basic science community to better understand the challenges and explore solutions that both fulfill the NIH commitment to transparency without creating confusion and unnecessary burden for BESH investigators.
The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information released in 2016 required BESH to register on ClinicalTrials.gov. FABBS and sister scientific societies expressed their concerns by submitting comments in response to an NIH Request for Information in August of 2018. While supporting research transparency and the intention to maximize the contributions of human research participants to advance science and improve public health, FABBS comments opposed the unintended consequences for behavioral and brain studies.
According to an analysis completed by staff at the National Library of Medicine, registering BESH on ClinicalTrials.gov poses four primary challenges:
- reporting requirements for multiple, interrelated small studies;
- apparent absence of prespecified primary outcome measures in the published articles;
- results reported for a few individual participants in a non-aggregated manner; and
- iterative preliminary studies to develop or optimize procedures.
While a delay of enforcement is certainly good news, FABBS looks forward to working with NIH to develop a final solution to best capturing BESH. During this interim period, NIH expects BESH investigators to register and report results on alternative platforms. Investigators are not required to do so on ClinicalTrials.gov.
Dr. Jeremy Wolfe, Harvard, served as the president of FABBS when NIH initially proposed changes to the definition of clinical trials and has continued to engage with NIH, including presenting on a panel, ‘Changing the Definition of Clinical Trials‘ at the Consortium on Law and Values in early 2019.
According to Dr. Wolfe, “This is real progress. I am grateful to NIH for listening closely to the concerns of the community and responding in this significant way. I am encouraged and look forward to continuing to work with NIH as they develop a sensible registration and reporting pathway for BESH research.”
For an overview, please visit NIH’s Expanding Definition of a Clinical Trial.