Ethical issues arising from characteristics of COVID-19 clinical trials registration in china

ObjectiveBy analyzing the information on COVID-19-related clinical trial registration in China from multiple perspectives, we explore the ethical issues involved to provide a basis for the standardization of clinical ethics for public health events such as emerging infectious diseases.

MethodsWe searched ClinicalTrials.gov and China Clinical Trials Registry (ChiCTR) for COVID-19-related clinical trials registered from January 1, 2020, to November 15, 2022, using keywords such as "2019-nCoV" and "COVID-19".We summarized and analyzed information on the spatial and temporal distribution characteristics, study types, interventions, study status, and ethics of clinical trial registration to identify and explore the ethical issues.

ResultsA total of 1 560 COVID-19-related clinical trials were included, of which 481 were registered on ClinicalTrials.gov and 1 079 were registered on ChiCTR.The peak period of clinical trial registration mas concentrated from February to April 2020;the number of clinical trials registration in Hubei, Shanghai, and Beijing was the Top 3 among all of the provincial administrative regions in China.Interventional studies (843/1 560, 54.00%) accounted for the highest percentage of all registration types, with registrations involving vaccines(202/843, 23.96%), chemicals(193/843, 22.89%), Chinese medicine(153/843, 18.15%) and biologics(90/843, 10.68%), and many other categories; the clinical trials that lacked informed consent, lacked ethical review and chose not to disclose trial results accounted for 11.40%(178/1 560), 3.33%(52/1 560) and 19.66%(307/1 560), respectively.

ConclusionsAt present, there are a large number of COVID-19-related clinical trials registered, but the scientific and ethical norms of some clinical trials still need to be regulated and improved.