NIH Taking Steps to Build a Better System for BESH Registration and Reporting

December 15, 2020

The National Library of Medicine (NLM), the unit at the National Institutes of Health (NIH) that oversees the ClinicalTrials.gov database, hosted a webinar on December 7^th to update the research community. NLM staff have conducted an analysis of the challenges of registration and results reporting of Basic Experimental Studies with Humans (BESH) in ClinicalTrials.gov.

William Riley, Director of NIH’s Office of Behavioral and Social Sciences Research (OBSSR), opened the webinar by providing a rationale for NIH’s registration and reporting push: to enhance research transparency, reduce publication bias, increase reporting of findings in a timely manner, and to honor the commitment to research participants and taxpayers. He added that although BESH is included in the clinical trials definition, there is a clear difference between basic and applied research involving humans.

Under current NIH guidance, there is flexibility in how scientists can report basic research involving humans. The flexibility, which is in place until September 24, 2021, will give NLM time to review the challenges and build a better system to accommodate BESH.

Rebecca Williams, Acting Director of ClinicalTrials.gov, described the model and key assumptions for ClinicalTrials.gov, and then acknowledged that many BESH studies do not fit neatly. Following up on a Request for Information in August 2018, she and colleagues conducted an extensive analysis to “try to understand and characterize issues” with which investigators were having difficulty. They evaluated protocol documents and talked to researchers directly, the latter involving nine Intramural Principle Investigators (PIs) from eight NIH Institutes and Centers, as well as three Extramural PIs recruited through FABBS and funded by the National Eye Institute, National Institute on Drug Abuse, and Eunice Kennedy Shriver National Institute of Child Health and Human Development.

During the webinar, Elisa Golfinopoulos, Technical Specialist, described four case studies that highlighted some of the challenges that were discovered in the NLM analysis. These included multiple, interrelated small experiments where the unit of reporting could be experiment, project, or research program; studies where the primary outcome measures were specified outside of the protocols; studies that report results for a few individuals and do not aggregate the results; and iterative preliminary studies that are conducted for the purposes of developing or optimizing procedures. The case studies illustrated the reporting challenges and what adaptations may be needed for BESH.

NLM staff also described four categories of interventional studies with humans and their fit with ClinicalTrials.gov. Basic exploratory interventional studies with humans were “inconsistent” with the ClinicalTrials.gov model and assumptions, according to their analysis. Other categories of interventional studies with humans (i.e., applied exploratory and basic confirmatory) were “accommodated by ClinicalTrials.gov.” Research studies that fell into an applied confirmatory category appear to be a “good fit” with ClinicalTrials.gov, according to the NLM analysis.

NLM staff stated that following their analysis, they discussed the findings and issues with the PIs, who themselves had a number of suggestions for developing a BESH reporting system:

• Leverage existing documents (e.g., publications, annual reports (NIDB), RePORTER, IRB-approved consent forms);
• Allow for narrative summaries with figures and images to provide sufficient context to understand BESH;
• Allow flexibility in reporting as research adapts/changes based on new findings; and,
• Allow use of different or more inclusive platforms than ClinicalTrials.gov (e.g., a HumanResearch.gov)

NLM, in collaboration with OBSSR, will continue working with the basic research community to address BESH registration and reporting. At this time, it is not clear whether there will be an expansion of ClinicalTrials.gov to accommodate BESH research or whether other reporting models will be explored. NLM staff will continue their quality control review for ClinicalTrials.gov, being “cognizant of how the research landscape is shifting.”

For now, PIs need to register and report results of BESH research on “some platform… with sustainability” that is “not home-grown,” according to Bill Riley, although the preference is for PIs to use ClinicalTrials.gov, if possible. If assistance is needed, NLM staff have offered to provide one-on-one help.

Watch the webinar on the NIH website.

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