Reason Analysis for Suspension/Early Termination of Drug Clinical Trial
Journal Title: Journal of Pharmaceutical and Biomedical Sciences - Year 2017, Vol 7, Issue 12
Abstract
Object To collect a scientific basis for improving the quality and success rate of drug clinical trials by analyzing the reasons for the suspension or termination of clinical trials in China and abroad. Method Drug Clinical Trials Registration and Information Disclosure Platform (chinadrugtrials.org.cn) and ClinicalTrials.gov (www.clinicaltrials.gov) were searched from August 1,2007 to August 1, 2017. Searches were conducted using the status “suspended” or “terminated”. Result From August 1, 2007 to August 1, 2017, the drug clinical trials of total items of which 6.30% were suspended/terminated prematurely. In the main type, by comparing the cause on Chinese and foreign clinical trials to suspend/early termination type, the results show that the two groups are similar distribution. By comparing the causes of subtypes, the most common reason for the termination of clinical trials abroad is the difficulty of recruiting subjects. The most common cause of suspension of domestic clinical trials is the decision of the sponsor. Conclusion About 59.09% of the clinical trials were due to nothing to do with the test data to suspend or early termination. While reasons are corrected, we can take the initiative to minimize the probability of clinical trials to be suspended.
Authors and Affiliations
Ying Liufu, Guohua Cheng, YiZhen Zhang, Rong Wang, Siyi Liu
Keywords
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