Reporting and design of randomized controlled trials for COVID-19: A systematic review

Contemp Clin Trials. 2021 Feb;101:106239. doi: 10.1016/j.cct.2020.106239. Epub 2020 Dec 3.

Abstract

Background: The novel coronavirus 2019 (COVID-19) pandemic has mobilized global research at an unprecedented scale. While challenges associated with the COVID-19 trial landscape have been discussed previously, no comprehensive reviews have been conducted to assess the reporting, design, and data sharing practices of randomized controlled trials (RCTs).

Purpose: The purpose of this review was to gain insight into the current landscape of reporting, methodological design, and data sharing practices for COVID-19 RCTs.

Data sources: We conducted three searches to identify registered clinical trials, peer-reviewed publications, and pre-print publications.

Study selection: After screening eight major trial registries and 7844 records, we identified 178 registered trials and 38 publications describing 35 trials, including 25 peer-reviewed publications and 13 pre-prints.

Data extraction: Trial ID, registry, location, population, intervention, control, study design, recruitment target, actual recruitment, outcomes, data sharing statement, and time of data sharing were extracted.

Data synthesis: Of 178 registered trials, 112 (62.92%) were in hospital settings, median planned recruitment was 100 participants (IQR: 60, 168), and the majority (n = 166, 93.26%) did not report results in their respective registries. Of 35 published trials, 31 (88.57%) were in hospital settings, median actual recruitment was 86 participants (IQR: 55.5, 218), 10 (28.57%) did not reach recruitment targets, and 27 trials (77.14%) reported plans to share data.

Conclusions: The findings of our study highlight limitations in the design and reporting practices of COVID-19 RCTs and provide guidance towards more efficient reporting of trial results, greater diversity in patient settings, and more robust data sharing.

Keywords: Coronavirus; Novel coronavirus 2019; Randomized controlled trials; Systematic literature review.

Publication types

  • Systematic Review

MeSH terms

  • COVID-19* / epidemiology
  • COVID-19* / prevention & control
  • COVID-19* / therapy
  • Data Management / organization & administration
  • Data Management / standards
  • Humans
  • Quality Improvement
  • Randomized Controlled Trials as Topic* / methods
  • Randomized Controlled Trials as Topic* / standards
  • Randomized Controlled Trials as Topic* / statistics & numerical data
  • Research Design / standards
  • Research Design / statistics & numerical data
  • SARS-CoV-2