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A snapshot of the ongoing clinical research on COVID-19

Daniele Piovani1,2, Claudia Pansieri1,2, Laurent Peyrin-Biroulet3

  • 1Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, 20090, Italy.

F1000Research
|June 11, 2020
PubMed

Insights

Clinical trials for coronavirus disease 2019 (COVID-19) show many interventional studies have small sample sizes, potentially hindering the discovery of effective treatments. Ensuring well-designed, adequately powered trials is crucial for evidence-based strategies.

Area of Science:

  • Clinical trial design
  • Epidemiology
  • Public health

Background:

  • The COVID-19 pandemic necessitates rapid development of diagnostic, preventive, and therapeutic strategies.
  • Thousands of patients are enrolled in clinical studies during the pandemic.

Purpose of the Study:

  • To investigate the characteristics of COVID-19 studies registered in ClinicalTrials.gov.
  • To assess the incorporation of features desirable for high-quality evidence generation in these studies.

Main Methods:

  • Analysis of 945 COVID-19 studies registered in ClinicalTrials.gov as of April 28, 2020.
  • Categorization of studies by type, allocation scheme, blinding, and primary purpose.

Main Results:

  • 586 (62.0%) studies were interventional, with parallel group assignment being the most frequent (74.6%).
  • Most interventional studies were open-label, with treatment research as the primary purpose.
  • A significant number of interventional studies had small expected sample sizes, potentially compromising evidence credibility.

Conclusions:

  • Many ongoing COVID-19 interventional studies may not generate credible evidence due to inadequate sample sizes.
  • This could delay the identification of effective therapies and waste resources.
  • Well-designed, adequately powered clinical trials are essential for evidence-based decision-making during the COVID-19 pandemic.
Keywords:
2019 novel coronavirus2019-nCoVCovid-19SARS-CoV-2severe acute respiratory syndrome coronavirus 2

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