Background: Recruitment to randomised-controlled trials (RCTs) is difficult. Poor recruitment can lead to time and budget extensions, potentially producing an underpowered study which fails to answer the research question. In the worst cases RCTs may be abandoned, causing huge waste. Thus, recruitment is considered a priority in trial-methods research.

Objectives: To understand how participant recruitment impacts the day-to-day lives of those charged with the task, we conducted a qualitative study with trial stakeholders. This will help methodologists to understand the on-the-ground challenges of recruitment, enabling them to make more-effective design decisions about future recruitment research to help ensure RCTs recruit to target.

Methods: Purposive and convenience sampling of trial stakeholders from the UK National Health Service, academia and industry. Individuals categorised themselves as ‘designers’; those who design recruitment methods, or ‘recruiters’; those who implement recruitment strategies. One-to-one interviews were conducted using a semi-structured topic guide either in person or over the telephone, and lasted approximately one hour.

Results: We interviewed 23 individuals with diverse recruitment experiences in roles such as Research Nurse, Clinical Trial Educator, Research Manager and Professor of Health Services. Our sample had 11 ‘recruiters’ and 12 ‘designers’; 19 from the UK, 2 from South Africa, 1 from Canada and 1 from Italy. Framework analysis was used to analyse interview transcripts and themes were identified within 3 broad concepts: 1) Current practice for designing recruitment strategies, highlighting the use of strategies lacking evidence of benefit; 2) What information stakeholders would find useful regarding evidence-based strategies; and, 3) How best to present evidence related to recruitment methods that have been used in RCTs to date.

Conclusions: The results give a clear view of current recruitment practice, which is far from evidence-based. Our findings point to how current evidence can be best presented to inform recruitment decisions as well as highlight what sort of evidence future research should provide.