Global landscape of randomized controlled trials responding to the COVID-19 pandemic: a literature review protocol

Abstract

Introduction: Evidence-based care is challenging during public health crisis. During the COVID-19 pandemic, although the tremendous number of clinical trials were conducted, small trials were prevalent, which posed the risk of duplication, heterogeneity, underreporting and limited applicability of the trial results to patients in the clinical setting. These factors are known to potentially jeopardize the efficient production of scientific data for evidence-based care. The objective of this review is to critically appraise the characteristics of randomized controlled trials related to COVID-19 therapeutics and vaccines. This article is a protocol for literature review.  Methods: This review will include randomized controlled trials (RCTs) on therapeutics and vaccines for COVID-19. Therapeutics include a single drug or a combination of multiple drugs for COVID-19. Non-human trials will be excluded. The search strategy is designed for identifying publication of study results in peer-review journals. Databases to be searched include MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Web of science and CINAHL. Two or more independent reviewers will screen identified publications for inclusion/exclusion and retrieve data including standard information of studies and specific details about RCT designs as well as reporting, for which we will follow the set of information in international trial registries and the CONSORT statement.  Discussion: It remains unclear what should be improved or strengthened for ecosystems of clinical trials for future pandemics. This review is expected to provide a landscape of RCTs related to COVID-19 therapeutics and vaccines and to explicitly show successful factors for evidence generation in response to pandemics.