Impact of Institutional Review Board Type and Food and Drug Administration Diversity Action Plan Draft Guidance on Demographics of Participants Enrolled in Phase 3 Clinical Trials Conducted from 2020 to 2024
Description
Clinical trial enrollment data from phase 3 studies conducted between 2020 and 2024 listed on clinicaltrials.gov. IRB of record for each study (as available) was added for each trial.
Files
Steps to reproduce
Using the clinicaltrials.gov search engine, a search was conducted for Phase 3 interventional clinical trials started and completed between 2020 and 2024 with posted results. Search results were then downloaded into an Excel file. The downloaded trial information included 30 data fields for each study. The data of interest for this study included the National Clinical Trial (NCT) number, study title, condition being studied, sex, age, total enrollment, start and completion dates, funding source, and trial locations. Studies were excluded if they enrolled participants outside of the U.S, did not have any enrollment, or were terminated without completion. The trial information downloaded from clinicaltrials.gov did not include participant ethnicity or race which was required for assessing representation. However, this data was available from the results tab within each trial’s webpage on clinicaltrials.gov. The race and ethnicity data were manually transcribed from the trial’s webpage and added to the clinical trial spreadsheet. After the initial data entry was completed, data transcription was reviewed for accuracy by an additional researcher. To determine if there was a relationship between the type of IRB used to approve the trial and participant representation, the IRB name was extracted from the consent form or protocol, when available. For trials that did not specify the IRB name, a search of PubMed was conducted using the NCT trial number. The type of IRB listed in the consent form or publications was determined by reviewing IRB information from the institution’s website. When the IRB information was not included in the publication or the study was not published, an e-mail was sent to the study contact requesting the IRB name and type. If no response was received from the initial e-mail, a follow-up e-mail was sent 1-2 weeks later. If no response was received from the follow-up e-mail, the IRB was categorized as “not reported”. For studies without contact information for a specific person, an inquiry was submitted via the organization’s website. When the IRB could not be determined, it was categorized as other/not reported. Clinical trials that relied on multiple IRBs were included in “other”.
Institutions
- University of Jamestown