Analysis of common protocol deviations in drug clinical trials of rheumatism
10.3760/cma.j.cn141217-20220602-00232
- VernacularTitle:风湿性疾病药物临床试验中常见方案偏离及分析
- Author:
Yan LIU
1
;
Jie BAI
;
Yanfei MU
;
Shasha ZHENG
;
Xiaoying ZHANG
;
Xiaoxia WANG
Author Information
1. 山西医科大学第二医院风湿免疫科，太原 030001
- Keywords:
Rheumatic diseases;
Clinical trials;
Pragram evaluation
- From:
Chinese Journal of Rheumatology
2023;27(6):393-397
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The common protocol deviation (PD) in clinical trials of drugs for rheumatic diseases were analyzed to provide reference for improving the quality of clinical trials and protecting the safety and rights of subjects.Methods:Protocol deviation (PD) reports of completed projects conducted by Department of Rheumatology and Immunology, the Second Hospital of Shanxi Medical University, from 2017 to 2021 were collected and sorted out for analysis. Results:The common PD and proportion of deviation were deviation from protocol study procedures (25.4%, 44/173), low medication compliance (23.7%, 41/173), visits out of the scheduled visit dates or the tests or examinations out od the inspection window period (19.1%, 33/173), missed visit or missed laboratory tests (17.9%, 31/174), using of prohibited drugs (9.2%, 16/173) and violation of inclusion criteria or exclusion criteria (4.6%, 8/173). 135 cases were mild and 38 cases severe deviation. PPS was eliminated in 5 subjects during statistical analysis.Conclusion:①Investigator training should be strengthened and the operability should be taken into account in clinical trial design. In the implementation process, the inclusion and exclusion criteria should be strictly followed and the should adherent to study procedures. ②The institution should actively promote the development of hospital information system to reduce investigator associated PD. ③The education and management of subject should be strengthened to ensure their compliance and improve the quality of clinical trials to protect the safety and rights of subjects. ④Institute should strengthen the management of trail supervisors and emphasis on problems identification during inspections.
