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Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges

Susan Halabi1,2, Jinyi Zhou1, Yijie He1

  • 1Department of Biostatistics and Bioinformatics, Duke Health, Durham, NC, USA.

Clinical Trials (London, England)
|July 5, 2022
PubMed
Abstract

Insights

Clinical trials for coronavirus disease 2019 (COVID-19) often lacked definitive results due to small sizes and varied designs. Global coordination is needed to harmonize endpoints and improve trial outcomes for effective COVID-19 therapies.

Area of Science:

  • Clinical trial design
  • Epidemiology
  • Drug development

Background:

  • Coronavirus disease 2019 (COVID-19) cases and deaths continue to rise globally.
  • Novel therapeutic interventions for COVID-19 are urgently required.
  • Assessing the design of clinical trials is crucial for developing effective treatments.

Purpose of the Study:

  • To critically review the landscape of clinical trials designed during the COVID-19 pandemic.
  • To assess the design of phase II/III and phase III interventional trials for COVID-19.
  • To identify trends and limitations in COVID-19 clinical trial methodologies.

Main Methods:

  • A systematic survey of clinical trials registered on ClinicalTrials.gov.
  • Inclusion criteria: trials registered between December 1, 2019, and April 11, 2021.
  • Data extracted included trial characteristics, outcomes, interventions, and patient demographics.

Main Results:

  • 57% of studies were interventional, with 14.5% being phase III trials.
  • Most therapeutic trials focused on hospitalized patients.
  • Significant variability in outcomes, disease severity, and comparators; trials were often underpowered.

Conclusions:

  • Findings highlight the need for global coordination in clinical trial design.
  • Advocating for common platforms to harmonize endpoints and key variables.
  • Clearer definition of disease severity is essential for clinically meaningful COVID-19 trial results.
Keywords:
COVID-19designendpointsphase III clinical trialsplatformtreatment

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