1.Expert consensus on the phase 0 clinical trials of positron-emitting radiopharmaceuticals (2025 edition)
Lu WANG ; Jinghao WANG ; Kuan HU ; Dongning YAO ; Benzhi CAI ; Chen SHI ; Baofeng YANG ; Rui WANG
China Pharmacy 2025;36(15):1825-1831
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.
2.Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein
Xiaofeng NI ; Sha DIAO ; Siyi HE ; Xuefeng JIAO ; Xiao CHENG ; Zhe CHEN ; Zheng LIU ; Linan ZENG ; Deying KANG ; Bin WU ; Chaomin WAN ; Binwu YING ; Hui ZHANG ; Rongsheng ZHAO ; Liyan MIAO ; Zhuo WANG ; Xiaoyu LI ; Maobai LIU ; Benzhi CAI ; Feng QIU ; Feng SUN ; Naihui CHU ; Minggui LIN ; Wei SHA ; Lingli ZHANG
China Pharmacy 2023;34(4):391-396
OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.