Abstract
Background: Although discontinuation is common in clinical trials, no study has been conducted to analyse the current situation and reasons for the suspension or discontinuation of drug clinical trials in China. This study aims to analyse the general characteristics and reasons for the discontinuation of registered clinical trials in mainland China and to identify the associated factors.Methods: Trials with a status of terminated or stopped in the Drug Trial Registration and Information Publication Platform before March 31, 2020, were classified as discontinued trials and included in the analysis. Information related to researchers, studied drugs, the trials and the reasons for discontinuation were recorded. Fisher’s exact and χ2 tests were used to examine the associations of trial characteristics with different issues related to trial discontinuation. Results: Three hundred and twelve discontinued trials were included in this study. The studied drugs were mainly chemical drugs [229 (73.4%)]. The indications of the studied drugs were mainly neoplasms [77 (24.7%)]. The study type was mainly bioequivalence studies [97 (31.1%)]. More than half [177 (56.7%)] of the trials were discontinued because of trial issues, among which the main causes were negative results [69 (22.1%)], protocol issues [41 (13.1%)], and poor recruitment [35 (11.2%)]. Ninety-five (30.4%), 15 (4.8%) and 26 (8.3%) trials were discontinued because of sponsor issues, research centre issues and administration issues, respectively. Study design, blinding status, number of centres, planned sample size and whether participants had been enrolled may have been associated with one to three of the issues related to trial discontinuation.Conclusions: Discontinuation of clinical trials was commonly due to trial issues, sponsor issues, research centre issues and administration issues, such as negative results, and protocol issues. Study design, the number of centres, and sample size may be related to the discontinuation of trials. Careful study designs, smart business decisions, sufficient preparation of supplies such as the research drugs, and whether research centres have enough availability and patients are factors that should be considered before conducting trials.
General Characteristics and Reasons for the Discontinuation of Drug Clinical Trials in Mainland China
