Evaluating the discoverability of supporting research materials in ClinicalTrials.gov for US federally funded COVID-19 clinical studies.

Abstract

The objective of this study was to evaluate the discoverability of supporting research materials, including supporting documents, individual participant data (IPD), and associated publications, in US federally funded COVID-19 clinical study records in ClinicalTrials.gov (CTG). Study registration records were evaluated for (1) links to supporting documents, including protocols, informed consent forms, and statistical analysis plans; (2) information on how unaffiliated researchers may access IPD and, when applicable, the linking of the IPD record back to the CTG record; and (3) links to associated publications and, when applicable, the linking of the publication record back to the CTG record. 206 CTG study records were included in the analysis. Few records shared supporting documents, with only 4% of records sharing all 3 document types. 27% of records indicated they intended to share IPD, with 45% of these providing sufficient information to request access to the IPD. Only 1 dataset record was located, which linked back to its corresponding CTG record. The majority of CTG records did not have links to publications (61%), and only 21% linked out to at least 1 results publication. All publication records linked back to their corresponding CTG records. With only 4% of records sharing all supporting document types, 12% sufficient information to access IPD, and 21% results publications, improvements can be made to the discoverability of research materials in federally funded, COVID-19 CTG records. Sharing these materials on CTG can increase their discoverability, therefore increasing the validity, transparency, and reusability of clinical research.