Abstract
BackgroundMany randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT.MethodsWe constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named “What is Important for Making a Study Successful questionnaire” (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively.ResultsResponses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%).ConclusionsFor recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.Trial registrationThe protocol for this study was registered at the Northern Ireland Hub for trials methodology research (SWAT ID 64). The EFFECTS study has EudraCT number 2011–006130-16 and was registered 17 February 2016 at ClinicalTrials.gov number NCT02683213.
Highlights
Many randomised controlled trials (RCT) fail to meet their recruitment goals
There is a need for more research in this area [3, 4] and in the UK finding methods to enhance recruitment in RCTs has been identified as being of the highest priority [5, 6]
Sixty-six percent were not accustomed to working with clinical trials; EFFECTS was the first trial in which they have participated (Table 1)
Summary
Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT. Introduction A common problem with randomised controlled trials (RCT) is that the recruitment is slow and fails to meet the recruitment goal in time [1]. Study personnel at centres play a crucial role in recruiting and retaining patients in clinical trials. Workshop and in-depth interview studies have investigated barriers to and opportunities for recruitment in clinical studies and found that it is still a challenge; new recruitment interventions are needed [10, 11]
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