Developing a national platform for delivering efficient trials for people living with stroke: the Life after Stroke Platform (LEAP)

<ns7:p>Background In the UK, over 100,000 people have a stroke annually. Over 1.3 million live with the effects of stroke, including problems with mobility, communication, cognition, anxiety, depression and fatigue. Previous research has tested single interventions to improve stroke outcomes in separate, fixed design, parallel-group trials. Evidence generation has been slow and inefficient. Adaptive trial designs are required, to better understand multiple treatments, targeting multiple questions simultaneously. We undertook to develop the first efficient adaptive platform trial protocol, aligned with national research priorities for ‘Life After Stroke’. Methods We embedded PPI activities throughout the platform development and co-developed resources to maximise equality, diversity, and inclusion. We established an inclusive multidisciplinary collaboration to inform design choices and future UK-wide platform delivery. We scrutinised existing research to identify candidate interventions and relevant outcomes; agreeing these with collaborators and PPI. We undertook detailed simulations to inform choice of platform design (adaptive elements, allocation, numbers of interventions, decision criteria for dropping/adding arms, interim analyses timing/frequency; intermediate outcomes choice). We explored barriers to trial and intervention participation through in-person and virtual meetings. To facilitate rapid trial set-up, we engaged with stroke research leaders and data providers; reviewed platform randomisation requirements; and widely disseminated our learning. Results We developed an efficient, adaptive trial protocol, which is feasible, inclusive and acceptable to stroke survivors and services and submitted a funding application for a platform trial testing at least five pre-determined non-pharmacological interventions for post-stroke emotional difficulties, the top research priority for ‘Life After Stroke’. Conclusions The complex and inclusive platform trial design has only been possible through UK-wide multidisciplinary collaboration with stroke researchers, trialists, clinicians, methodologists, third sector, and patient and public contributors. Such a trial would be a step-change in trial design, reducing research waste and accelerating evidence generation to inform improved stroke service provision world-wide.</ns7:p>