Implications of the lack of a unified research project framework: an investigation into the registration of clinical trials of COVID-19

Abstract

Objective: The aim of this study was to provide recommendations for improving the design of subsequent studies through analysis of the registered coronavirus disease 2019 (COVID-19) clinical trials.

Methods: A retrospective analysis of 189 trial retrievals achieved on 20 February 2020.

Results: A total of 189 trials are included in the study. There were 69.3% interventional studies, 21.7% observational studies, 5.3% diagnostic tests and 3.7% other studies. The following statistics are provided only for the interventional studies. Severity of disease: 5.3% light and common type, 17.6% severe and critically ill and 59.6% with no restricted classification. Medication use: 51.1% Western medicine, 32.1% Chinese medicine, 10.7% blood related product and 6.1% non-drug therapy. The median and inner quantile range of the sample sizes included in these studies: 104 (IQR: 60, 200). Primary outcome type most used: 45.8% with clinical characteristics and 21.4% with virological. Study design characteristics: 71% of all studies were randomized, 5% of all studies were blinded, 18% of all studies were multicenter and 76% of all studies were single center.

Conclusion: Although many COVID-19 studies include randomization in their design, the lack of additional double-blind and placebo-controlled elements in their designs result in a less robust evaluation of intervention safety and efficacy. Furthermore, similar or repeated research and small sample studies that have less promise in gains of new information have possibly led to a shortage of recruitable patients and become a barrier to the completion of large multicenter clinical trial studies.

Keywords:

• Coronavirus disease 2019
• COVID-19
• clinical trials
• investigation
• recommendations

Transparency

Declaration of financial/other relationships

No potential conflict of interest was reported by the authors. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

B.W. designed the study, analyzed data and composed the first draft of the paper. B.W. and J.L. collected data. J.L. performed language editing. X.Y. and F.J. contributed to manuscript discussion. C.Y. gave critical comments and revised the manuscript. All of the authors have read and approved the final manuscript.

Acknowledgements

We would like to thank all of the medical staff for their efforts in fighting the epidemic during the outbreak.

Additional information

Funding

This work was supported by National Science and Technology Key Project [No. 2017ZX10106001003].