Achieving recruitment targets is a challenge to every clinical trial’s success. Ovarian cancer (OC) accounted for 1.7% of all cancers diagnosed in Europe in 2012, equating to 238,719 women. As these patients have limited treatments available, it is essential that OC trials achieve their recruitment targets to prevent early termination and unanswered research questions. There is evidence to suggest that the characteristics of the recruiter has an influence on a patient’s clinical trial acceptance, however there is little real world evidence to support this. The aims, and primary outcomes, of this study were to determine if recruiter characteristics reported in OC clinical trials have an influence on recruitment targets and timelines. The secondary outcome was the number of OC clinical trials with publically available recruitment strategies.
A two-step search strategy was applied to identify OC clinical trials. 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 and clinicaltrials.gov. Data extracted were recorded as dichotomous variables (reported=1, not reported=0).
A total of 88 OC clinical trials were included. 31% (n=28) made reference to the recruiter but this was reported only in the protocol. 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. Due to poor reporting, it is not possible to determine whether recruiter characteristics in clinical trials have any influence on recruitment targets or timelines. None of the trials included published their recruitment strategy. Two trials (2%) referred to recruitment strategies in the protocol.
It was not possible to determine the influence of recruiter characteristics on recruitment timelines and targets due to a lack of reporting. None of the included trials published their recruitment strategies. Reporting standards of recruiter characteristics and recruitment strategies must improve to allow identification of effective interventions and dismissal of ineffective ones. This should be done through addition to the CONSORT statement.