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

Abstract: Background: Activities related to clinical trials (recruitment of participants, delivery of the intervention and follow up appointments) are often undertaken in person. Many such activities, such as measuring blood pressure, or prescribing medications, are difficult to undertake remotely. COVID-19 related social distancing has meant that in order to continue, clinical trials are having to adapt the way they undertake trial procedures. This situation provides an opportunity to investigate new ways of undertaking clinical trials that may improve the efficiency of trials after the pandemic. Aims of the research: The aim of the project is to identify the adaptations CTUs are making in order to incorporate COVID-19 related social distancing and identify those adaptations that may improve the efficiency of trials after the pandemic. Design and methods: The study will be undertaken in 3 stages. Firstly, a survey will be distributed to all CTUs to identify the changes that have been made to trials. Secondly, 6 trials will be selected for further investigation. Those staff involved in the selected studies will be interviewed in order to discuss the changes that have been made and the lessons learnt. Lastly, at the end of the project a workshop will be held with those involved in the clinical trials (both patient representatives, clinicians and academics) in order to develop guidance which will detail adaptations that can be made to trials in order to improve their efficiency. Patient and public involvement: PPI members will be identified from individuals who are already providing PPI input into the selected studies. PPI representatives will be invited to attend the workshop, where their input will be sought into the guidance. Dissemination: The guidance document will be distributed to all registered CTUs in the UK, and will be published in a journal in order to achieve wider dissemination.