The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial has been named David Sackett Trial of the Year by the Society for Clinical Trials (SCT). The award was presented today at the Society for Clinical Trials’ 42nd Annual Meeting.
Every year since 2008, the SCT has awarded the David Sackett Trial of the Year Award to a randomised, controlled trial published in the previous calendar year that best fulfills the following standards:
- improves the lot of humankind;
- provides the basis for a substantial, beneficial change in health care;
- reflects expertise in subject matter, excellence in methodology, and concern for study participants;
- overcomes obstacles in implementation; and
- based on the presentation of its design, execution, and results is a model of clarity and intellectual soundness.
The RECOVERY trial is a large, pragmatic randomised trial for the treatment of hospitalised patients with suspected or confirmed COVID-19. It was designed and implemented at extraordinary speed in the midst of the COVID-19 pandemic, at a time of great need for effective treatments to reduce mortality among hospitalised patients.
‘The RECOVERY trial is well chosen for this year’s award which was presented on International Clinical Trials Day,’ said Dr Susan Halabi, President of SCT and Professor of Biostatistics and Bioinformatics, Duke University. ‘The COVID-19 pandemic underscored the importance of responding with agility while still maintaining scientific rigor. What we've learned from the RECOVERY trial is that scientific achievements can be made expeditiously. This trial is a superb example of that; the scientific team did not sacrifice science for efficiency, and carefully planned efficiency fostered agility. The RECOVERY trial highlights the immense and positive impact that clinical trials have on the world, especially during the pandemic. Engagement of several thousands of volunteers is truly impressive. Lastly, this trial would serve as a model for efficient design for future clinical trials for all diseases.’
‘This year, the Trial of the Year Committee received several nominations for outstanding trials, including those that have arguably had the most profound impact on public health during a pandemic: the COVID-19 vaccination trials,’ said Dr. Marc Buyse, Chair of the SCT Trial of the Year Committee. ‘Whilst all nominated trials would have deserved the award, the vote finally went to RECOVERY not just because of its spectacular speed, efficiency, and pragmatism, but also because this trial will have a lasting impact on how trials should be conducted in all disease areas going forward.’
Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for the RECOVERY trial, said ‘This award is a testament and a tribute to the exceptional work of many thousands of people working under the most difficult circumstances. 2020 was awful in so many ways but the RECOVERY trial was uplifting, showing what can be achieved when there is unity, resolve and a commitment to good science. RECOVERY is a truly national achievement and every person involved should feel incredibly proud. I would encourage them to regularly remind themselves that there are many thousands of people who are only alive today thanks to their efforts.’
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Joint Chief Investigator, said ‘The COVID-19 pandemic has highlighted the critical role that randomised trials play in determining how best to treat disease. When we started the RECOVERY trial in March 2020, our key motivation was to provide reliable evidence about the effects of possible treatments at a scale and speed that would inform treatment decisions and lessen the impact of the pandemic. We were able to combine the fundamental principles of large randomised trials, exemplified in the studies of treatment for acute myocardial infarction in the 1980s, with the scale of the UK National Health Service and the data that it collects as part of its everyday business.
‘The RECOVERY journey has been extraordinary for everyone involved and it has been hugely rewarding to see how the results have transformed the way COVID-19 is treated worldwide. Clinical trials require teamwork and collaboration and we have been overwhelmed by the strength of support and involvement of so many frontline NHS clinicians who have embraced the trial as part of delivering high quality care to their patients, and to the patients without whom this would not have been possible. I would particularly like to thank my colleagues at the coordinating centre whose expertise and dedication have been exceptional.’
Treatments tested initially included lopinavir-ritonavir, two drugs used to treat HIV, dexamethasone, an anti-inflammatory drug, and hydroxychloroquine, a treatment for malaria. Due to its large size, the trial could show quickly and reliably that lopinavir-ritonavir and hydroxychloroquine were ineffective, while dexamethasone reduced mortality by one-third in patients receiving invasive mechanical ventilation and by one-fifth in patients receiving oxygen. These landmark findings changed clinical practice worldwide.
The trial has randomised almost 40,000 participants to date, and is still actively recruiting in more than 180 clinical sites in the UK and internationally. It is currently testing Regeneron’s combination of monoclonal antibodies directed against coronavirus, baricitinib, an immunomodulatory drug used in rheumatoid arthritis, and dimethyl fumarate, an immunomodulatory drug used for psoriasis and multiple sclerosis.
Nominations for the Trial of the Year are submitted by Society members, investigators, and interested scholars from around the world. Dr David L. Sackett was a dedicated long-time SCT member and a pioneer in evidence-based medicine and champion of clinical trials.