Phased subjects management strategy of phaseⅠclinical trials for new drug
10.13699/j.cnki.1001-6821.2016.13.025
- VernacularTitle:药物Ⅰ期临床试验受试者的分阶段管理策略
- Author:
Bo JIA
;
Nan ZHAO
;
Zi-Ning WANG
;
Xia ZHAO
;
Pei-Hong SUN
;
Yi-Min CUI
- Keywords:
phaseⅠclinical trial;
subjects management;
recruitment;
screening;
observation
- From:
The Chinese Journal of Clinical Pharmacology
2016;32(13):1236-1239
- CountryChina
- Language:Chinese
-
Abstract:
In order to obtain the phase I clinical trial data safely and accurately , the subjects management is very important .The purpose of this paper is to introduce the subjects management model during recruitment , screening and observation and discuss the phase I subjects management strategy , according to the author ’ s practical experience and the working model of phase I clinical trials in hospital .
