Summary document: Learning from COVID-19 related trial adaptations to inform efficient trial design - a sequential mixed methods study

Background Activities related to clinical trials (recruitment of participants, delivery of the intervention and follow up appointments) are usually undertaken in person, some of which, including measuring blood pressure, or prescribing medications, are difficult to undertake remotely. COVID-19 pandemic related social distancing has meant that to continue, clinical trials have had to adapt the way they undertake trial procedures. The aim of this study was to understand the adaptations that have been made by clinical trials units (CTUs) during the pandemic, and whether these adaptations have the potential to improve the efficiency of trials after the pandemic. An online survey was distributed to 53 UK Clinical Research Collaboration (UKCRC) registered CTUs to identify the adaptations that have been made to trials as a result of the pandemic up until early 2021 (work package 1, WP1). Case studies were then selected for further investigation by reviewing the survey responses, selecting relevant and promising adaptations whilst ensuring variation in key characteristics (e.g., CTU, disease area). Staff involved in the selected case studies were interviewed to discuss the changes that have been made, lessons learnt, and the potential for the adaptation to improve the efficiency of future trials post-pandemic (WP2). The interviews were transcribed verbatim and analysed qualitatively. Findings were reviewed by a group of CTU and patient representatives at an online workshop (WP3) that focused on the potential of these adaptations to improve efficiencies in trials post-pandemic.