Abstract
BackgroundRecruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful.MethodsA scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March–June 2018. Qualitative data were analysed using a content analysis and inductive approach.ResultsResponses from 24 (46%) CTUs identified that database-screening tools were the most widely used digital tool for recruitment, with the majority being considered effective. The reason (and to whom) these tools were considered effective was in identifying potential participants (for both Site staff and CTU staff) and reaching recruitment target (for CTU staff/CI). Fewer retention tools were used, with short message service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: ‘security and transparency’; ‘inclusivity and engagement’; ‘human interaction’; ‘obstacles and risks’; and ‘potential benefits’. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants.ConclusionsOur studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high-quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.
Highlights
Recruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging
Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high-quality evidence to support their use
Reviews of clinical trials funded by the UK Medical Research Council (MRC) and the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme [2] have shown that the proportion of trials achieving their original recruitment target was in the range of 31%–56%, and 79% of trials achieving at least 80% of the final target sample size (119/151, trials reporting from 2004 to April 2016) [3, 4]
Summary
Recruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful. Given the lack of high-quality evidence and certainty around resource-intensive techniques to improve recruitment and retention, trialists and Clinical Trials Units (CTUs) are increasingly exploring the value of digital tools as a more viable option to identify, recruit and retain participants. Existing literature investigating the use of digital technology/tools for recruitment to and retention in clinical trials has mainly focused on: Eligibility: searches and interactive medical record tools to support clinicians screening participants [11]; Recruitment: trial websites, social media and email campaigns to engage with the broader public [12,13,14,15]; Retention: emails, interactive websites, text messages or apps to retain participants enrolled in trials and help them adhere to the trial intervention [9, 10, 16,17,18]
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