Speaker: Heidi Gardner
Date to be confirmed.
This is a talk at the International Clinical Trials Methodology Conference (ICTMC), Brighton, UK, 6th – 9th October 2019. Venue is the Hilton Brighton Metropole.
Authors: Heidi Gardner, Shaun Treweek, Katie Gillies
Participant recruitment to trials is challenging. To date research has focussed on recruitment once the trial has started, rather than planning strategies to support it e.g. developing information leaflets with user feedback. We aimed to explore if people involved with participant recruitment have explicit strategies, and if so, how these are developed, and if not, what barriers prevent effective planning.
One-to-one qualitative semi-structured interviews. Data were analysed using a framework approach, themes were linked through comparison of data within and across stakeholder groups.
23 trialists; 11 self-identifying as ‘Designers’; those responsible for designing recruitment methods, and 12 self-identifying as ‘Recruiters’; those who recruit participants. Interviewees’ experience with interventions, clinical areas, and recruitment expertise were diverse.
UK NHS primary, secondary and tertiary-care sites involved in trials, academic institutions (UK, the Netherlands, Canada) and contract research organisations supporting pharmaceutical companies (UK, South Africa, Italy).
To varying degrees, respondents had prospective strategies for recruitment. These were never explicitly based on evidence of recruitment benefit.
Two main themes encapsulated barriers to strategy development:
- Timing of grant applications; time-pressures due to tight deadlines often result in rushed planning followed by an ‘amendment cascade’ after recruitment commences.
- Research governance; trialists are often over-burdened with administrative tasks resulting from this amendment cascade.
Themes relating to the types of environments needed to facilitate successful recruitment also emerged; communication and relationship-building within and across teams involved in multi-centre trials; recruitment support, and trialists’ workload.
Respondents from all countries considered limited preparation times and disproportionate approvals processes as major structural challenges to recruitment planning. Poor planning is a mistake that trial teams live with throughout the trial. Effective recruitment requires strategies to increase the time available for trial planning, as well as access to evidence-based strategies that can be straightforwardly implemented.