Analysis of Reasons for Suspension of Drug Clinical Trials Between China and Other Countries

Abstract

Objective: To analyze the various reasons for the suspension of drug clinical trials, provide suitable solutions to reduce the incidence of such suspensions, prevent wastage of resources, and enhance the completion rate of clinical trials. Method: Relevant information on drug clinical trials suspended in China and other countries was retrieved from “Drug Clinical Trial Registration and Information Disclosure Platform” and “ClinicalTrials.gov”. Various factors were statistically summarized, comparing the reasons for clinical trial suspensions between China and other countries, and analyzing differences among groups in various classification variables, including indications, years, trial phases, and types of drugs. Result: A total of 323,248 drug clinical trials were conducted internationally, with a suspension rate of 0.48% (1,564/323,248). Within this dataset, China reported 377 suspended clinical trials, constituting 1.66% (377/22,703) of its total studies, while other countries conducted a total of 300,545 clinical trials, resulting in a suspension rate of 0.39% (1,187/300,545). The primary cause of suspension in various countries was attributed to issues related to sponsors and funding. Notably, there existed a statistically significant difference in the number of suspended trials between China and other countries (p < 0.05). Conclusion: During the research preparation phase, sponsors should meticulously assess the feasibility of clinical trials and exercise prudence in development decisions. The clinical trial protocol design must prioritize safety and scientific validity. Research teams should be equipped with emergency risk control measures, adhere to pertinent laws and regulations governing clinical trial, and ensure adequate management. Thus, drug clinical trials can only be conducted with high quality, thereby ensuring the progression of drug marketing.