Preprint Review Version 1 This version is not peer-reviewed

What Makes the UK Recovery Trial More Pragmatic than the European Discovery Trial?

Version 1 : Received: 17 June 2020 / Approved: 18 June 2020 / Online: 18 June 2020 (09:23:27 CEST)

How to cite: Han, R.; Liang, S.; Biernikiewicz, M.; Wang, Y.; Toumi, M. What Makes the UK Recovery Trial More Pragmatic than the European Discovery Trial?. Preprints 2020, 2020060229 (doi: 10.20944/preprints202006.0229.v1). Han, R.; Liang, S.; Biernikiewicz, M.; Wang, Y.; Toumi, M. What Makes the UK Recovery Trial More Pragmatic than the European Discovery Trial?. Preprints 2020, 2020060229 (doi: 10.20944/preprints202006.0229.v1).

Abstract

The objective of this study was to review the study design and preliminary results of the Recovery trial and analyze the implementability of the Recovery trial by comparing it with the European Discovery trial.Method: The study design of the Recovery trial in the latest version of protocol was described and deeply analyzed to address the issue of implementation of the trial. A comparative analysis of study design and implementation between the UK Recovery trial and the European Discovery trial was conducted following the description.Results: The Recovery trial is a pragmatic, randomized, controlled, adaptive, open-label clinical trial. The study design of the Recovery trial was reported in the ISRCTN registry, the EU Clinical Trials Register and the U.S. National Library of Medicine ClinicalTrials.gov registry. Initially published on the 13th March 2020, the study protocol of the Recovery trial has been updated five times at the time of this writing. More than 11,000 patients have been enrolled and 80% have completed the follow-up. Thousands of health care professionals at 175 Trusts in the UK have been involved. Conclusion: The Recovery trial applies a study design to address the issue of implementation in the context of the COVID-19 pandemic and emergency. It was conceptually pragmatic with a clear vision to address the top priority: the control of mortality and rational use of scarce resources. By contrast, the Discovery trial was designed as an intellectual exercise and consequently failed to address the issue of implementation in emergency.

Subject Areas

SARS-CoV-2; COVID-19; Recovery trial; Discovery trial

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