Subject management and ethical considerations in clinical trials of hypoglycemic drugs
10.3760/cma.j.cn113565-20211112-00175
- VernacularTitle:基层医院降糖药物临床试验中受试者管理与伦理考虑
- Author:
Panpan SHI
1
;
Fen SHEN
;
Limei SONG
;
Fengli ZHAO
Author Information
1. 山西省运城市中心医院药物临床试验中心 044000
- Keywords:
Diabetes;
Clinical trials;
Ethics;
Subjects;
Compliance
- From:
Chinese Journal of Medical Science Research Management
2022;35(2):107-111
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the main management points and ethical considerations of diabetic subjects involved in hypoglycemic drug clinical trials.Methods:Taking the subject management of a hypoglycemic drug clinical trial in Yuncheng Central Hospital as an example, the problems and measures in the subject management of diabetic patients were systematically discussed.Results:In hypoglycemic drug clinical trial that involving diabetic patients, ethical considerations regarding to the subjects' rights, safety and health should take into account in the whole process of subjects' recruitment, screening, enrollment and follow-up.Conclusions:Subject management taking into account of ethical consideration can better protect the safety and rights of subjects, enhance the compliance of subjects and improve the quality of drug clinical trials.
