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The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly emerged as a major threat to healthcare systems across the globe, resulting in the launch of unprecedented containment efforts by governments worldwide. In many countries, quarantines and stay-at-home orders have been imposed in an attempt to flatten the epidemiological curve and mitigate the acute burden of COVID-19 on hospitals and clinics. Such measures may remain necessary until a safe and effective therapy or vaccine against the disease has been developed.
In response to the present pandemic, the US Food and Drug Administration and the European Medicines Agency (EMA) have set up programmes1 2 to incentivise and expedite the development of COVID-19 treatments and vaccines. The International Coalition of Medicines Regulatory Authorities has stressed the importance of randomised controlled trials (RCTs) for generating the robust level I evidence required to support the uptake of promising therapeutic strategies into clinical practice.3 Currently, more than 1000 interventional studies investigating over 400 different anti-SARS-CoV-2 drug candidates are being conducted.4 However, the vast majority of these are small, single-country or even single-centre trials,5–8 despite the fact that EMA has called for the pooling of resources into large, multiarm, multicentre, multicountry RCTs.9 Although such limited-scale studies have their …
Contributors Both authors contributed to the writing of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.