Using Evidence when Planning for Trial Recruitment: An International Perspective from Time-poor Trialists

Introduction: Recruiting participants to trials is challenging. To date, research has focussed on improving recruitment once the trial is underway, rather than planning strategies to support it, e.g. developing trial information leaflets together with people like those to be recruited. We explored whether people involved with participant recruitment have explicit planning strategies; if so, how these are developed, and if not, what prevents effective planning.

Methods: Design: Individual qualitative semi-structured interviews. Data were analysed using a Framework approach, and themes linked through comparison of data within and across stakeholder groups. Participants: 23 international trialists (UK, Canada, South Africa, Italy, the Netherlands); 11 self-identifying as 'Designers'; those who design recruitment methods, and 12 self-identifying as 'Recruiters'; those who recruit participants. Interviewees' had recruitment experience spanning diverse interventions and clinical areas. Setting: Primary, secondary and tertiary-care sites involved in trials, academic institutions, and contract research organisations supporting pharmaceutical companies.

Results: To varying degrees, respondents had prospective strategies for recruitment. These were seldom based on rigorous evidence. When describing their recruitment planning experiences, interviewees identified a range of influences that they believe impacted success: The timing of recruitment strategy development relative to the trial start date, and who is responsible for recruitment planning.The methods used to develop trialists' recruitment strategy design and implementation skills, and when these skills are gained (i.e. before the trial or throughout).The perceived barriers and facilitators to successful recruitment planning; and how trialists modify practice when recruitment is poor.

Conclusions: Respondents from all countries considered limited time and disproportionate approvals processes as major challenges to recruitment planning. Poor planning is a mistake that trialists live with throughout the trial. The experiences of our participants suggest that effective recruitment requires strategies to increase the time for trial planning, as well as access to easily implementable evidence-based strategies.