Literature DB >> 34286192

Making trials part of good clinical care: lessons from the RECOVERY trial.

Guilherme Pessoa-Amorim1,2, Mark Campbell1,2, Lucy Fletcher3, Peter Horby4, Martin Landray5, Marion Mafham6, Richard Haynes7.   

Abstract

When COVID-19 hit the UK in early 2020, there were no known treatments for a condition that results in the death of around one in four patients hospitalised with this disease. Around the world, possible treatments were administered to huge numbers of patients, without any reliable assessments of safety and efficacy. The rapid generation of high-quality evidence was vital. RECOVERY is a streamlined, pragmatic, randomised controlled trial, which was set up in response to this challenge. As of April 2021, over 39,000 patients have been enrolled from 178 hospital sites in the UK. Within 100 days of its initiation, RECOVERY demonstrated that dexamethasone improves survival for patients with severe disease; a result that was rapidly implemented in the UK and internationally saving hundreds of thousands of lives. Importantly, it also showed that other widely used treatments (such as hydroxychloroquine and azithromycin) have no meaningful benefit for hospitalised patients. This was only possible through randomisation of large numbers of patients and the adoption of streamlined and pragmatic procedures focused on quality, together with widespread collaboration focused on a single goal. RECOVERY illustrates how clinical trials and healthcare can be integrated, even in a pandemic. This approach provides new opportunities to generate the evidence needed for high-quality healthcare not only for a pandemic but for the many other conditions that place a burden on patients and the healthcare system. © Royal College of Physicians 2021. All rights reserved.

Entities:  

Keywords:  COVID-19; RECOVERY; evidence-based medicine; quality-by-design; randomised controlled trials

Year:  2021        PMID: 34286192      PMCID: PMC8285150          DOI: 10.7861/fhj.2021-0083

Source DB:  PubMed          Journal:  Future Healthc J        ISSN: 2514-6645


  47 in total

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2.  Early safety indicators of COVID-19 convalescent plasma in 5,000 patients.

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Journal:  J Clin Invest       Date:  2020-06-11       Impact factor: 14.808

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Authors:  Amanda M Rojek; Genevieve E Martin; Peter W Horby
Journal:  BMC Med       Date:  2020-08-21       Impact factor: 8.775

7.  Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis.

Authors:  Christopher W Jones; Ashley L Woodford; Timothy F Platts-Mills
Journal:  BMJ Open       Date:  2020-09-17       Impact factor: 2.692

8.  Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Authors: 
Journal:  Lancet       Date:  2021-02-02       Impact factor: 79.321

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10.  Enhancing clinical evidence by proactively building quality into clinical trials.

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Authors:  Stephen R Hanney; Sharon E Straus; Bev J Holmes
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2.  Establishing COVID-19 trials at scale and pace: Experience from the RECOVERY trial.

Authors:  Leon Peto; Peter Horby; Martin Landray
Journal:  Adv Biol Regul       Date:  2022-07-19

3.  Large scale clinical trials: lessons from the COVID-19 pandemic.

Authors:  Alex R Horsley; Laurence Pearmain; Sean Knight; Nick Schindler; Ran Wang; Miriam Bennett; Rebecca C Robey; Jane C Davies; Ratko Djukanović; Liam G Heaney; Tracy Hussell; Stefan J Marciniak; Lorcan P McGarvey; Joanna Porter; Tom Wilkinson; Chris Brightling; Ling-Pei Ho
Journal:  BMJ Open Respir Res       Date:  2022-06

4.  The end of the COVID-19 pandemic.

Authors:  John P A Ioannidis
Journal:  Eur J Clin Invest       Date:  2022-04-05       Impact factor: 5.722

Review 5.  Pharmacological Studies in Hospitalized COVID-19 Patients in Belgium: We Could Do Better.

Authors:  Maya Hites; Jean-Louis Vincent
Journal:  Viruses       Date:  2022-06-29       Impact factor: 5.818

6.  COVID-19 models and expectations - Learning from the pandemic.

Authors:  John P A Ioannidis; Stephen H Powis
Journal:  Adv Biol Regul       Date:  2022-10-08

7.  Clinical trial research agenda on COVID-19 - the first two years in Germany and beyond.

Authors:  Julian Hirt; Perrine Janiaud; Lars G Hemkens
Journal:  Z Evid Fortbild Qual Gesundhwes       Date:  2022-09-27

Review 8.  Clinical Evidence Generation During a Pandemic: Lessons Learned for Sustaining Progress.

Authors:  Donna R Rivera; Paul G Kluetz; Kald Abdallah; Sundeep Agrawal; Derek C Angus; Robert M Califf; Elizabeth Garrett-Mayer; Randall Hyer; Douglas R Lowy; Samir N Khleif
Journal:  Cancer J       Date:  2022 Mar-Apr 01       Impact factor: 2.074

  8 in total

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