Recruitment, Recruitment, Recruitment – But Do We Collect and Report All The Information We Should? A Retrospective Review of Ovarian Cancer Trials in A 10-Year Period

Abstract Background Achieving recruitment targets is a challenge to every clinical trial’s success. Evidence suggests that the recruiter has an impact on a patient's decision to participate in a clinical trial but there is no evidence that it improves recruitment rates. The aim of this study was to determine if the person who recruits the participants to the trial impacts recruitment timelines and targets. We chose ovarian cancer clinical trials to test this. A secondary outcome was to identify if trialists published their recruitment strategies. Methods We identified a body of ovarian cancer (OC) clinical trials between 2010 and 2021. Searches were conducted in CINAHL, PubMed, Medline (OVID and EBSCO) and separately in the New England Journal of Medicine, American Cancer Society Journals, Lancet Oncology, Journal of Clinical Oncology and BMC Cancer. We also identified all associated protocols or supplementary material associated with each trial. We reviewed 139 papers, 30 protocols, 105 registry entries and 26 trial websites associated with 88 phase III OC trials. Results Of the 88 trials, only 31% (n=28) made reference to the recruiter but this was reported only in the protocol so we have no evidence these named recruiters performed the task. Seventy-nine trials were registered on a clinical trial registry, but only 11 (14%) of these included a protocol. None of the trials reviewed published a recruitment strategy or made reference to an available recruitment strategy for the trial. None of the trials reviewed which closed early, or extended recruitment timelines due to slow accrual, reported measures taken to improve recruitment rates before stoppages or changes took place. There were disparities in the reported target recruitment numbers between the protocol, the publication and the registry. Conclusions Trialists need to think carefully about the trial data they collect, the reasons for collection and who the data collection is for. They also need to increase the transparency of their practices. We believe the inclusion of a patient or member of the public at the design phase of the trial would assist this focus.