key: cord-0875404-xfn72o42 authors: Ramanan, Mahesh; Stolz, Annaliese; Rooplalsingh, Rajiv; Billot, Laurent; Myburgh, John; Venkatesh, Bala title: An evaluation of the quality and impact of the global research response to the COVID‐19 pandemic date: 2020-09-18 journal: Med J Aust DOI: 10.5694/mja2.50790 sha: 4fba052bc56a02a4f5c880a719083d7b5078fb10 doc_id: 875404 cord_uid: xfn72o42 nan To the Editor: The initial months of the coronavirus disease 2019 (COVID-19) pandemic have led to an unprecedented response from the global medical research community. 1 Simultaneously, there have been concerns about the rapid publication of misleading, biased studies. 2 We systematically evaluated the early global research response to COVID-19 by characterising the methodological quality of registered COVID-19 studies. We also compared the research response with previous respiratory viral epidemics: the severe acute respiratory syndrome (SARS), the Middle East respiratory syndrome (MERS) and the influenza A(H1N1) pdm09 virus pandemic. We reviewed COVID-19 studies registered from 1 January to 6 May 2020 in five international clinical trial registries: • Clinicaltrials.gov 3 The global research response to COVID-19 has been substantially larger than that observed with previous epidemics and pandemics. The potential drivers of this include the absence of proven therapies, 3 ease of transmissibility, 4 rapidity of global spread, and high hospitalisation and mortality rate 5 coupled with greater pandemic preparedness and ease of greater global collaboration. It is concerning that only a minority of trials adhered to established markers of internal validity, such as blinding, allocation concealment, placebo where applicable, and a data safety monitoring committee presence. The high discontinuation rate of trials within 5 months into the pandemic could be due to data from case series and observational studies indicating lack of benefit or even harm with the interventions being tested in RCTs, loss of equipoise, or control of the pandemic resulting in fewer eligible patients for enrolment. The trade-off for the rapid expansion of COVID-19 research has been the suspension of non-COVID-19 research in several jurisdictions, and a substantive shift by granting bodies to prioritise COVID-19 research funding away from non-COVID-19 research applications. 6, 7 While the global research response to COVID-19 has been rapid and substantial, due to methodological insufficiencies, many studies of interventions may not lead to high quality evidence to guide treatment of COVID-19. Resulting publications from these studies and reasons for discontinuation of studies would be of interest for future investigation. There was significant duplication with multiple trials of several interventions. The impact on non- COVID-19 Clinical Research Coalition. Global coalition to accelerate COVID-19 clinical research in resourcelimited settings Rapid publishing in the era of coronavirus disease 2019 (COVID-19) Pharmacologic treatments for coronavirus disease 2019 (COVID-19): a review Early transmission dynamics in Wuhan, China, of novel coronavirusinfected pneumonia Clinical characteristics of coronavirus disease 2019 in China Clinical trials suspended in UK to prioritise COVID-19 studies and free up staff Coronavirus shuts down trials of drugs for multiple other diseases