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正电子类放射性药物0期临床研究专家共识（2025年版）
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| 篇名： | 正电子类放射性药物0期临床研究专家共识（2025年版） |
| TITLE： | Expert consensus on the phase 0 clinical trials of positron-emitting radiopharmaceuticals （2025 edition） |
| 摘要： | 目的 为规范医疗机构开展正电子类放射性药物0期临床研究（以下简称“0期临床研究”）、推进药物创新研发提供参考。方法由暨南大学附属第一医院牵头，联合国内多家单位的药学、临床及医学伦理学专家，通过调研相关现状，结合国家相关政策、法规制度和专家共识，对医疗机构开展0期临床研究的工作条件和流程等内容进行系统研讨，达成一致意见，形成共识。结果与结论目前大部分医疗机构在放射性药物管理及其0期临床研究过程中均存在药学服务方面的不足。本共识结合《关于设立核药师岗位的专家共识》，在2020年版《正电子类放射性药物0期临床研究申请工作专家共识》的基础上，增加和明确了核药师在0期临床研究过程中的工作职责，为我国医疗机构核药师高质量参与0期临床研究工作提供指导；并基于目前相关制度的局限，提出鼓励医疗机构牵头组建区域联合体、建设专业化基地或产业园区等策略建议，对于支持和加强医疗机构开展0期临床研究、推进放射性药物创新具有重要意义。 |
| 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. |
| 期刊： | 2025年第36卷第15期 |
| 作者： | 王璐；王景浩；胡宽；姚东宁；蔡本志；史琛；杨宝峰；王锐 |
| AUTHORS： | WANG Lu，WANG Jinghao，HU Kuan，YAO Dongning，CAI Benzhi，SHI Chen，YANG Baofeng，WANG Rui |
| 关键字： | 正电子类放射性药物；0期临床研究；药物创新；药学服务；核药师 |
| KEYWORDS： | positron-emitting radiopharmaceuticals； phase |
| 阅读数： | 9 次 |
| 本月下载数： | 2 次 |
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