Endpoints for randomized controlled clinical trials for COVID-19 treatments.

Clinical Trials : Journal of the Society for Clinical Trials
Lori E DoddThomas Jaki

Abstract

Endpoint choice for randomized controlled trials of treatments for novel coronavirus-induced disease (COVID-19) is complex. Trials must start rapidly to identify treatments that can be used as part of the outbreak response, in the midst of considerable uncertainty and limited information. COVID-19 presentation is heterogeneous, ranging from mild disease that improves within days to critical disease that can last weeks to over a month and can end in death. While improvement in mortality would provide unquestionable evidence about the clinical significance of a treatment, sample sizes for a study evaluating mortality are large and may be impractical, particularly given a multitude of putative therapies to evaluate. Furthermore, patient states in between "cure" and "death" represent meaningful distinctions. Clinical severity scores have been proposed as an alternative. However, the appropriate summary measure for severity scores has been the subject of debate, particularly given the variable time course of COVID-19. Outcomes measured at fixed time points, such as a comparison of severity scores between treatment and control at day 14, may risk missing the time of clinical benefit. An endpoint such as time to improvement (or recove...Continue Reading

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Citations

Dec 12, 2020·The New England Journal of Medicine·Andre C KalilUNKNOWN ACTT-2 Study Group Members
Dec 17, 2020·Clinical Trials : Journal of the Society for Clinical Trials·Deborah A Zarin, Stephen Rosenfeld
Feb 4, 2021·British Journal of Clinical Pharmacology·Michael DoddsCraig R Rayner
Mar 6, 2021·Trials·Elias Laurin MeyerUNKNOWN EU-PEARL (EU Patient-cEntric clinicAl tRial pLatforms) Consortium
Mar 19, 2021·Open Forum Infectious Diseases·Youngji JoBrooke E Nichols
Jun 3, 2021·The Canadian Journal of Cardiology·Perrine JaniaudJohn P A Ioannidis
Jun 7, 2021·BMC Medical Research Methodology·Lonni BesançonClémence Leyrat
Jul 1, 2021·Statistics in Biopharmaceutical Research·Nigel StallardThomas Jaki
Sep 24, 2021·Journal of Biopharmaceutical Statistics·Samvel B GasparyanGary G Koch
Oct 23, 2021·European Journal of Immunology·Hector Rincon-ArevaloEva V Schrezenmeier

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