INTRODUCTION: Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers.
METHODS: A respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP.
RESULTS: On integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence.
DISCUSSION: Integrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.
|Number of pages||5|
|Journal||BMJ Open Respiratory Research|
|Publication status||Published - 6 Jul 2021|
Bibliographical noteFunding Information:
Acknowledgements The authors would like to thank respiratory consultants Dr Anjali Crawshaw, Dr Patricia Glynn, Dr Jon Naylor, Dr Benjamin Sutton, Dr Richard Thompson and Dr Ian Woolhouse and respiratory registrars Dr Louise Crowley, Dr Atena Gogokhia, Dr Clara Green, Dr Frances Grudzinska, Dr Sebastian Lugg, Dr Emily Mckemey, Dr Gulfam Mussawar, Dr Peer Ameen Shah, Dr Shaun Thein as well as the entire RSU MDT for their help and contribution in ensuring the successful running of the clinical care pathway and management of the Respiratory Support Unit. RECOVERY-RS was funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Contributors KPY was responsible for the data analysis and interpretation as well as drafting of the manuscript. DP and DPD were responsible for the conception, data acquisition, interpretation and critical appraisal of the manuscript. SG, CS, JW, SM, SSAH, FR, NS, JTen, JTra, BC, KF and SB were responsible for data acquisition and critical appraisal of the manuscript. All authors have given approval for the final form of this manuscript.
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
- Critical Pathways
- Patient Selection
- Randomized Controlled Trials as Topic
- Respiratory Therapy
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine