Clinical Research Nurse predictions of trial failure, recruitment and retention: A case for their early inclusion in trial design

Abstract Background Clinical research nurses are a key part of the clinical trial team but typically get involved later in the trial, usually during recruitment. The purpose of our study was to establish if CRNs who read the trial protocol can predict the performance of the trial. Methods We randomly selected 18 trial protocols with three statuses, terminated, withdrawn, completed, from clinicaltrials.gov, between 2014 and 2018 inclusive. We gave the protocols to five clinical research nurses, asked them to make a judgement and provide a reason for that judgement (via a 12-item questionnaire) on the status of the trial (terminated, withdrawn or completed), if the trial met its recruitment target, if it recruited on time, if it retained its participants. We also asked if it was likely a CRN was involved in the design of the trial. The CRNs were blinded to the study outcomes, did not receive any training on how to read a protocol and undertook to not use the internet while completing the task. Results 23 questionnaires on 23 trials protocols (18 different trials) were completed by 5 CRNs. The CRNs correctly predicted the trial status 52% (12/23) of the time, successful/unsuccessful recruitment 74% (17/23) of the time, on-time recruitment 70% (16/23) of the time, participant retention 43% (10/23). CRNs identified 100% (sensitivity) of sites that hit their target and 67% (specificity) of sites that missed their target. Conclusions CRNs are a vital part of the clinical trial team and we have made a strong case for engaging them early in the design phase of the trial, potentially offsetting problems of recruitment, retention and trial failure.