Learning from COVID-19 Efficient Trial Adaptations
A sequential, mixed methods study funded by the National Institute for Health Research (NIHR), aiming to identify adaptations to trial recruitment and follow-up processes that have the potential to improve the efficiency of future clinical trials.
Many routine health care appointments, which were once undertaken face-to-face, are now being undertaken remotely (i.e. over the telephone or via video call) due to the social distancing rules put in place during the COVID-19 pandemic. These face-to-face appointments have, in the past, been used to recruit patients to clinical trials, or collect their follow-up data during a clinical trial. Therefore many clinical trials have had to adapt their procedures in order to carry on during the pandemic.
The need for trials to attempt to reduce in-person contact presents a rare opportunity to study novel adaptations in trials. It seems likely that post-pandemic healthcare will change and remote contact may become the new normal - clinical trials will need to adapt. Therefore, guidance is needed in order to assist CTUs and to inform the efficient design of trials post pandemic.
The aim of this project, which has been funded by the NIHR CTU Support Funding stream, is to find out how clinical trials have adapted to the pandemic, specifically focussing on the recruitment and follow-up of trial participants. The overall aim is to identify adaptations that have the potential to improve the efficiency of future clinical trials.
In order to do this we will undertake three work packages:
Work package 1: We will send a survey to all clinical trials units (departments that assist medical professionals in undertaking clinical trials) in the UK in order to identify studies that have made adaptations to their recruitment or follow-up procedures due to COVID-19, and that have the potential to improve the efficiency of clinical trials.
Work package 2: We will select five to eight case studies to collect detailed information about, which we will collect by interviewing the staff who were involved in the study. We will ask them about the adaptation they made to the study and the lessons they have learnt.
Work package 3: The data collected from the interviews will then be presented to a selection of researchers and patients at a workshop, where the trial adaptations will be discussed and a guidance document, which will suggest ways in which trials can be made to be more efficient, will be put together.
Can I submit a potential case study to you for the 1st work package?
Yes, please contact Robin Chatters (using the details provided below) if you would like to provide a potential case study.
How will you select case studies for the 2nd work package?
Case studies will be selected by the project management group, who will selected case studies based on the following criteria:
- The adaptation has improved, or is likely to improve, the recruitment rate, diversity of trial participants, or the efficiency (time and/or cost) of recruitment;
- The adaptation has improved, or is likely to improve, the retention of participants, completeness of data within the trial, or the efficiency (time and/or cost) of follow-up or outcome assessment;
- The adaptation meets one of the criteria described in 1) or 2) above, and the adaptation has been used frequently across multiple trials.
When might the guidance for CTUs be made available?
This will be made available in around October 2021.
Will trial participants/patients be involved in this study?
Yes, patient and public involvement (PPI) representatives who are already contributing to the trials selected as case studies will be asked if they would like to contribute to the workshop and the guidance document.
If you are interested in participating in this research, or have any questions, please contact the project lead:
Robin Chatters – firstname.lastname@example.org, 01142222969
- Robin Chatters - Sheffield Clinical Trials Research Unit, The University of Sheffield
- Professor Cindy Cooper - Sheffield Clinical Trials Research Unit, The University of Sheffield
- Professor Chris Burton – School of Health and Related Research, The University of Sheffield
- Professor Alicia O’Caithain - School of Health and Related Research, The University of Sheffield
- Professor Athene Lane - Bristol Trials Centre, University of Bristol
- Caroline Murphy - King’s Clinical Trial Unit, King’s College London
- Angela Cape - King’s Clinical Trial Unit, King’s College London
- Professor David Torgerson - York Trials Unit, The University of York
- Professor Jane Nixon - Leeds Clinical Trials Unit, The University of Leeds