Expert consensus on the phase 0 clinical trials of positron-emitting radiopharmaceuticals （2025 edition）
- VernacularTitle:正电子类放射性药物0期临床研究专家共识（2025年版）
- Author:
Lu WANG
1
;
Jinghao WANG
2
;
Kuan HU
3
;
Dongning YAO
4
;
Benzhi CAI
5
;
Chen SHI
6
;
Baofeng YANG
7
;
Rui WANG
3
Author Information
1. Dept. of Nuclear Medicine，the First Affiliated Hospital of Jinan University，Guangzhou 510630，China
2. Dept. of Pharmacy，the First Affiliated Hospital of Jinan University，Guangzhou 510630，China
3. Institute of Materia Medica，Chinese Academy of Medical Sciences，Beijing 100050，China
4. School of Pharmacy，Nanjing Medical University，Nanjing 211166，China
5. Dept. of Pharmacy，the Second Affiliated Hospital of Harbin Medical University，Harbin 150086，China
6. Dept. of Pharmacy，Union Hospital，Tongji Medical College，Huazhong University of Science and Technology，Wuhan 430022，China
7. School of Pharmacy，Harbin Medical University，Harbin 150081，China
- Publication Type:Journal Article
- Keywords:
positron-emitting radiopharmaceuticals;
phase
- From:
China Pharmacy
2025;36(15):1825-1831
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide a reference for standardizing the conduct of positron-emitting radiopharmaceuticals’ phase 0 clinical trials （hereinafter referred to as “phase 0 clinical trials”） and advancing the development of innovative drug by medical institutions. METHODS Initiated by the First Affiliated Hospital of Jinan University， a panel of experts consisting of pharmacy， clinical medicine and medical ethics from multiple institutions was established to investigate the current landscape， and discuss the necessary conditions， procedures， and other aspects for conducting phase 0 clinical trials in medical institutions by integrating relevant national policies， regulations and expert consensus. Finally， an agreement was reached to formulate this consensus. RESULTS & CONCLUSIONS Currently， most medical institutions have deficiencies in pharmaceutical care during the management of radiopharmaceuticals and the phase 0 clinical trials. In conjunction with the Expert Consensus on the Establishment of Nuclear Pharmacist Positions， this consensus explicitly defines the responsibilities of nuclear pharmacists in the phase 0 clinical trials on the basis of the Expert Consensus for the Application of Positron Emission Tomography Radioligands for Translational Study in the Phase 0 Clinical Trials （2020 edition）， providing a guidance for high-quality participation of nuclear pharmacists from medical institutions in China in phase 0 clinical research. Additionally， in consideration of some constraints imposed by current relevant regulations， this consensus also proposes strategic recommendations， such as encouraging medical institutions to form a consortium， leading to the establishment of dedicated bases or industrial parks， holding significant implications to strengthen institutional capacity for advancing radiopharmaceutical innovation through phase 0 clinical trials.
