Risks and suggestions of Investigator-Initiated Clinical Trial approvals based on drug supply and security
10.3760/cma.j.cn113565-20220403-00052
- VernacularTitle:基于药品供应保障探讨研究者发起的临床研究项目立项风险及建议
- Author:
Taotao YANG
1
;
Hua ZHOU
;
Jun CHEN
Author Information
1. 宁波市医疗中心李惠利医院 315000
- Keywords:
Drug;
Supply and security;
Investigator-Initiated Clinical Trial;
Approval;
Risk identification
- From:
Chinese Journal of Medical Science Research Management
2023;36(1):77-80
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To improve the standard and quality of clinical trials, the possible risks of Investigator-Initiated Clinical Trial(IIT) approvals based on drug supply and security were discussed and suggestions were put forward.Methods:According to the laws and regulations and literature review, concerning experimental drug supply and security during project negotiation, the risk points of IIT approvals were comprehensively analyzed and suggestions were put forward.Results:There are four main types of risks in assessing IIT approvals in terms of drug supply and security: drug entry and sales, drug promotion, discounts of observation fees, and concept confusion. Healthcare institutions should pay attention to and coordinate the IIT approvals.Conclusions:IIT is a supplement and extension of Industry Sponsored Trial(IST), which should be actively carried out by healthcare institutions while also paying attention to the security and risk prevention of drug supply, ensuring a standardized and orderly manner.
