Public availability of results of ClinicalTrials.gov‐registered expanded access studies

Abstract

Funding information Kosciuszko FoundationAims: Expanded access is the use of investigational treatments outside of clinical trials. Results of expanded access studies provide insights into how investigational treatments work in real-world settings. The objective of this study was to evaluate public availability of results of expanded access studies. Methods: Eligible expanded access studies were identified in ClinicalTrials.gov (CT. gov). Publications matching records of individual studies were searched for in Medline and Embase. In addition, we assessed whether results of the included studies were publicly available from other sources including CT.gov, sponsor web sites and conference proceedings.Results: After median time of 49.5 (interquartile range, 36.7-64.7) months from study completion, the results of 69 out of the 152 included studies (45.39%) were publicly available, either as a journal publication (53 studies; 34.87%) or from other source (16 studies; 10.52%). The percentage of studies whose results were available

Conflicts of interest in oncology expanded access studies

“…In fact, our recent study showed that after a median time of 49.5 months from study completion, the results of only 45.39% of ClinicalTrials.gov-registered expanded access studies were publically available. 31 Therefore, our results may not reflect the actual scale of the problem of COIs in programs providing access to anticancer treatments outside of clinical trials. However, there is no comprehensive source of data enabling one to examine COIs in oncology expanded access studies.…”