Preliminary study on the international distribution of phase Ⅰ clinical trials and the characteristics of research institutions
10.3760/cma.j.cn113565-20191104-00225
- VernacularTitle:对Ⅰ期临床试验国际分布及研究机构特点的初探
- Author:
Xue JIANG
1
;
Peixin HE
;
Ya TU
;
Xiaozhen LAI
;
Chaoqun REN
;
Xiaoye NIU
;
Yiyi LIU
;
Guanlin LI
Author Information
1. 北京大学第三医院 100191
- From:
Chinese Journal of Medical Science Research Management
2020;33(4):310-314
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analysis the construction of the world's top PhaseⅠclinical trial registration agencies, compare their size, composition, operation and funding, to provide further reference for the construction of clinical trial agency in China.Methods:Search for PhaseⅠclinical trial research agencies by region on clinicaltrials.gov. Collecting information about the agency’s management, staffing, implementation in Asia, America and Europe. Descriptive analysis was carried out to explore the type, proportion and operation among different regions, the organizational structure, operational management and effectiveness of each agency from different regions were compared.Results:The United States, Europe and East Asia are dense areas of PhaseⅠclinical research around the world. The types of agencies in the United States, Britain, France, Germany, South Korea, Japan, and Israel are mainly enterprises. Among other types of agencies, the organizational models are diversified. The agencies have different spatial distances from medical institutions, but possess relatively consistent scale and institutional operation. All the agencies have a stable source of funding.Conclusions:In order to strengthen the construction of clinical trial agencies in China, we should speed up the establishment of a close connection mechanism to promote deep cooperation in clinical trials. Control the construction scale and maintain stable input of the agency. Meanwhile, establish and strengthen international exchanges and cooperation.
