研究者发起临床研究的监管体系及其在生物医学新技术背景下的作用研究OA

Investigator-initiated trials(IITs)are clinician-led clinical studies that are not intended for medical product registration.Characterized by high flexibility,close alignment with clinical needs,and independence from commercial interests,IITs play a critical role in early proof-of-concept studies and translational research in the field of cell and gene therapy(CGT).They have become an important driver of biomedical innovation and evidence-based medicine in China.This paper briefly introduces the regulatory frameworks governing IITs in the United States,Japan,and the European Union,and systematically reviews and analyzes the regulatory framework,current implementation status,and existing challenges of IITs in China,and further proposes strategies and pathways for establishing a high-quality IIT governance system.Against the new backdrop of the newly issued Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies,this study is expected to support filing-based clinical research involving new biomedical technologies.It is of great significance for promoting the high-quality development of clinical research in China,accelerating the translation of innovative achievements,and enhancing international competitiveness.