Analysis of biospecimen management problems in drug clinical trials
Objective To analyze the problems existing in the management of biological samples in drug clinical trials,and to propose corresponding measures to ensure the quality of clinical trials.Methods The violation protocol reports submitted to the ethics committee from May 2019 to May 2023 were downloaded from the drug clinical trial management system of our hospital,and the biospecimen management-related violations were retrospectively analyzed,including the type,quantity,responsible subject,distribution of common violation regimen types in different clinical trial stages,comparison of violation types before and after the implementation of the new version of drug clinical trial quality management standards,and the impact of violation of the protocol.Results A total of 76 cases of violations related to biological samples were included in the 304 protocol violation reports,and the most common types of protocol violations were sample storage over-temperature(22 cases,accounting for 28.95%),collection over-window(14 cases,accounting for 18.42%),and centrifugation time over-window(8 cases,accounting for 10.53%).Conclusion Improve the quality management system of biological samples,strengthen the training of investigators'GCP regulations and protocols,improve the awareness and ability of investigators'GCP,generate high-quality biological samples,and facilitate the research and development of new drugs.
Drug clinical resarchNoncompliance/violation protocalBiological sample management
万方数据
维普
