Discussion on implementation risks and countermeasures of investigator-initiated pediatric drug clinical trials based on drug management
10.3760/cma.j.cn113565-20240131-00038
- VernacularTitle:基于药品管理探讨研究者发起的儿科药物临床研究实施风险及对策
- Author:
Chaohui YE
1
;
Yingyan YAN
;
Zhuoer ZHU
;
Yi CHEN
Author Information
1. 宁波大学附属妇女儿童医院 315012
- Keywords:
Investigator-initiated;
Drug clinical trial;
Drug management;
Pediatrics
- From:
Chinese Journal of Medical Science Research Management
2024;37(5):424-428
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aimed to discuss the risks associated with investigator-initiated pediatric drug clinical trials in terms of drug management and put forward relevant suggestions to improve the standardization and quality of pediatric clinical trials.Methods:The risk in the implementation of pediatric drug clinical trials initiated by domestic researchers were discussed and the countermeasures were put forward by reviewing literature, laws and regulations, and combining with the problems related to research drugs in project management.Results:In investigator-initiated pediatric drug clinical trials, the variety of research drug sources, such as sponsor donations, hospital pharmacy supplies, and community pharmacy provisions, posed distinct management risks that would require tailored attention. Moreover, the specific risk of pediatric medication should be fully considered during study execution. It was imperative for medical institutions to strengthen comprehensive management of research drugs to ensure the trial′s smooth operation.Conclusions:Investigator-initiated pediatric drug clinical trials serve as valuable supplements that expand new drugs′ trial scope for children. While actively conducting these trials, it is recommended that medical institutions should strengthen project approval reviews from the perspectives of drug supply, subject compensation and child dosage form, implement centralized management of research drugs, attach importance to ethical review of adverse drug events, strengthen personnel training and leverage information settlement, so as to improve work efficiency and research quality-ultimately providing support for pediatric pharmaceutical development efforts as well as promoting high-quality advancements within Chinese pediatrics medicine.
