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Feature Medical Research

RECOVERY trial: the UK covid-19 study resetting expectations for clinical trials

BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m1626 (Published 28 April 2020) Cite this as: BMJ 2020;369:m1626

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Rapid Response:

The research response to COVID-19: a paradigm for the future

Dear Editor

As clinical researchers in stroke we applaud the rapid mobilisation of clinical research into COVID-19 in response to this new global health threat. As deaths in UK hospitals and care homes from COVID-19 pass 30,000 (as of 6 May), nearly 100 urgent research studies in COVID-19 have been approved within just the last few weeks, many of them, like RECOVERY, complex clinical trials of drugs that would have taken months or even years to start before the pandemic. [1] This rapid progress has been achieved in part due to streamlined regulation and expedited approvals, whilst still preserving the rights of patients and the public.

However our admiration is tempered by frustration. Year after year, stroke kills around 40,000 people in the UK [2] – most of whom are older people with ‘underlying health conditions’ – and five and a half million people worldwide. [3] Globally stroke is the second leading cause of premature death, a situation expected to prevail for the next 20 years or more. [4] Worldwide, there are 80 million stroke survivors, many living with the disabling effects of stroke and it’s devastating social and economic consequences.[3] When we talk to patients with stroke and their families, they immediately grasp the urgency of stroke research, and they share our frustration when they hear of the disproportionate regulatory and bureaucratic hurdles that slow the approval, start-up and conduct of valuable research into their disease. [5]

So as clinical researchers in stroke we commend the rapid response of regulators and funders in support of our counterparts in virus and public health research in the face of this global public health emergency. Our call is to take this further, and to see the same streamlined and proportionate approach taken to research into the other major threats to worldwide health. Let one of the many lessons that nations learn from COVID-19 be a reappraisal of the regulatory burden for clinical research and audit into the leading communicable and non-communicable causes of death and disability, proportionate to the threat that these diseases represent. Let the evidence we have seen of streamlined and reduced regulation of clinical research result in the widespread adoption of new and enlightened approaches. At least some of the trauma and heartbreak of COVID-19 could be turned to good if it prompts a dramatic reduction in the burden of regulation, such that clinical research into all the big killers – communicable and non-communicable alike – is allowed to flourish unhindered.

1. https://www.hra.nhs.uk/covid-19-research/approved-covid-19-research/ (accessed 07 May 2020).
2. Office for National Statistics (2019). Deaths registered in England and Wales: 2018. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarri... (accessed 07 May 2020)
3. World Stroke Organisation Global Stroke Fact Sheet. https://www.world-stroke.org/publications-and-resources/resources/global... (accessed 07 May 2020).
4. Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017. Seattle, WA: IHME, 2018. http://www.healthdata.org/sites/default/files/files/policy_report/2019/G... (accessed 07 May 2020).
5. Al-Shahi Salman R, Beller E, Kagan J et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014; 383(9912): 176‒185.

Competing interests: No competing interests

07 May 2020
Martin A James
Consultant Stroke Physician/Clinical Professor
Professor Gary Ford (Oxford), Professor Thompson Robinson (Leicester), Professor Rustam Al-Shahi Salman (Edinburgh)
Royal Devon & Exeter NHS Foundation Trust/University of Exeter Medical School, Royal Devon & Exeter Hospital, EXETER EX2 5DW