Current status of registration of radiopharmaceutical clinical trials
10.3760/cma.j.cn112271-20250306-00079
- VernacularTitle:放射性药品临床试验注册现状分析
- Author:
Jiancai WU
1
;
Mengmeng WANG
;
Qiaoling LIU
;
Da ZHANG
;
Danhua LU
;
Huamei WANG
;
Ziqiao LEI
Author Information
1. 华中科技大学同济医学院附属协和医院药物临床试验机构，武汉 430000
- Publication Type:Journal Article
- Keywords:
Radiopharmaceutical;
Medical isotopes;
Clinical research;
Drug clinical trial
- From:
Chinese Journal of Radiological Medicine and Protection
2025;45(8):790-794
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the status of registration of clinical trials of radiopharmaceuticals in China, and to provide reference for the development and clinical application of radiopharmaceuticals.Methods:By searching the clinical trial registration and information disclosure platform of the Center for Drug Evaluation of the National Medical Products Administration (NMPA), the data on clinical trials of radiopharmaceuticals registered from 2014 to 2024 were collected and analyzed for trial design, administered dose, common indications, and geographical distribution.Results:A total of 77 clinical trials were included. The Compound Annual Growth Rate for the number of projects from 2014 to 2024 was 40%. Diagnostic radiopharmaceuticals were predominantly based on 18F and 99Tc m, while therapeutic radiopharmaceuticals primarily utilized 177Lu and 90Y. All indications were concentrated in the field of oncology. Regarding trial design, non-randomized (71.4%), open-label (89.6%), and single-arm (66.2%) trials accounted for the highest proportions. Geographical distribution showed Beijing (29 trials), Shanghai (18 trials), and Jiangsu province (14 trials) as the regions with the highest concentration of clinical trials. Conclusions:Radiopharmaceutical clinical trials in China have shown rapid growth. However, research remains predominantly focused on oncology, with a relatively high proportion of early-stage trials. In order to fully utilize the potentials of radiopharmaceuticals and improve the quality of clinical trials, nuclear medicine researches should broaden therapeutic applications, implement prudently administerd dose in clinical trials, and implement optimized radiation protection procedures across all clinical trial centers.
