NIH’s clinical trial definition includes prospective basic science studies involving human participants. Basic Experimental Studies with Humans (BESH) use an intervention to understand fundamental aspects of a phenomena without specific application towards processes or products in mind. NIH published clinical trial case studies with examples of BESH (cases 9, 14, 40 & 41).
NIH funded clinical trials, including BESH, are required to register and post results in ClinicalTrials.gov. On Monday, December 7th from 3:00-4:00 pm, Rebecca Williams, Acting Director of ClinicalTrials.gov, and Elisa Golfinopoulos will present the results of the National Library of Medicine analysis of challenges and considerations for registration and results information reporting of BESH in ClinicalTrials.gov. You may send questions before or during the event to SciencePolicy@od.nih.gov with the Subject “BESH Webinar”
Webinar: Monday, December 7, 2020 3:00-4:00 PM https://videocast.nih.gov/watch=40141
For more information about ClinicalTrials.gov, including assistance with registration, please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu.