Appealing for efficient, well organized clinical trials on COVID-19

Area of Science:

• Clinical Research Methodology
• Infectious Disease Epidemiology
• Public Health

Background:

• The rapid rise of COVID-19 clinical trials necessitated an analysis of their characteristics.
• Understanding ongoing and pending interventional trials is critical for scientific progress.

Purpose of the Study:

• To review and characterize interventional clinical trials for COVID-19.
• To identify potential defects in trial design, endpoints, and sample size.

Main Methods:

• Systematic review of 171 COVID-19 interventional trials registered in ChiCTR and ClinicalTrials.gov as of February 22, 2020.
• Classification of trials by treatment modality: chemical drugs (CDs), biological therapies (BTs), traditional Chinese medicine (TCM), and other therapies.
• Analysis focused on trial stage, design, randomization, blinding, primary endpoint (PE) definition, and sample size.

Main Results:

• Most trials employed parallel-arm designs (88.3%) and randomization (77.2%), but blinding was infrequent (14.6%).
• Over half of the trials planned to recruit 100 or fewer patients, potentially limiting statistical power.
• Traditional Chinese Medicine trials more frequently used multiple primary endpoints compared to chemical drugs or biological therapies.

Conclusions:

• Identified potential defects in COVID-19 trial designs, including inadequate sample sizes and primary endpoint definitions.
• Emphasized the need for scientifically sound, ethical, and patient-centered design in COVID-19 clinical trials.
• Highlighted the importance of robust trial methodology for generating reliable evidence on COVID-19 treatments.