Status and Analysis of 832 Investigator-Initiated Coronavirus-Related Clinical Studies
Download PDF
$currentUrl="http://$_SERVER[HTTP_HOST]$_SERVER[REQUEST_URI]"

Keywords

Investigator-initiated
Clinical research
COVID-19
Data analysis

DOI

10.26689/jcnr.v7i6.5399

Submitted : 2024-04-10
Accepted : 2024-04-25
Published : 2024-05-10

Abstract

Objective: To contribute to the development of clinical research on novel coronavirus by analyzing the clinical research data of COVID-19. Methods: Searches were performed on the database of “National Health Insurance Information Platform Medical Research Registration Information System” using the keywords “COVID-19” and “Novel coronavirus.” The search was performed till 31 December 2022. This paper presents a statistical analysis of the status quo of the registered projects in terms of the number of registered projects, the types of projects, the levels of the institutions, the types of research, the intervention measures, the research design, the main objectives of the research, and so on. Results: A total of 823 investigator-initiated clinical studies of COVID-19 were documented, and the number of studies registered peaked on December 31, 2020, and December 31, 2022. Among them, there were 819 items from general medical research (99.5%), 812 items from medical institutions (98.7%), and 713 items from Medical Grade III, and Class A hospitals (86.6%). Among these items, 534 (64.9%) were observational studies. The most common intervention method used was administering existing drugs, with 140 studies utilizing them. This data analysis also included 128 case-control studies and 247 treatment-oriented studies. Conclusion: Researchers in local medical institutions have been actively carrying out clinical research related to COVID-19. However, they should refer to registered research to avoid duplicate research.

References

Cheng X, Shu Z, Xu W, et al., 2022, Key Points of Investigator-Initiated Clinical Research Project Management Under the New Situation. Herald of Medicine, 41(2): 266–270.

Li Q, Guo S, Kong Y, et al., 2020, Analysis and Thinking of Clinical Trial Registration Projects Under the COVID-19 Epidemic. Journal of Clinical and Experimental Medicine, 19(10): 1029–1033.

Chu Z, Zhang Y, Jiang M, et al., 2022, Analysis of the Status and Development Countermeasures of Clinical Research Initiated by A Researcher in a Hospital. Chinese Journal of Pharmacoepidemiology, 31(12): 850–853.

Bhide A, Shah Ps, Acharya G, 2018, A Simplified Guide to Randomized Controlled Trials. Acta Obstet Gynecol Scand, 97(4): 380–387.

Zhang H, Guo X, Ye X, et al., 2022, Sensitivity Analysis Method for the Control of Confounders in Observational Studies. Chinese Journal of Pharmacoepidemiology, 31(04): 240–247.

Wang J, Xu C, Xin B, 2019, Challenges and Reflections on the Ethical Review of Clinical Research. Chinese Medical Ethics, 32(11): 1392–1400.

Mu Y, Zhao L, Li G, et al., 2014, Questions and Reflections on Medical Ethics in Clinical Research Management. World Chinese Medicine, 9(07): 945–947.

Fauci AS, Lane HC, Redfield RR, 2020, COVID-19-Navigating the Uncharted. N Engl J Med, 382: 1268–1269.