Study on the Correlation between IIT and IST Management in America,Europe,and Japan for CGT Products and its Implications for China
Cell and gene therapy(CGT)is a key direction for the future development of the global biopharmaceutical industry and exhibits immense potential applications in the treatment of severe or refractory diseases where traditional treatments are ineffective.In China,due to the unique nature of CGT products,most companies initiate investigator-initiated trials(IIT)at the early stages of research to preliminarily assess the safety and efficacy of the products.However,currently,the results of IIT in China cannot be directly applied and must transition to industry-sponsored clinical trials(IST)conducted by pharmaceutical companies,followed by drug registration and marketing approval processes.Therefore,this paper systematically reviews the regulatory status of CGT and IIT in various countries and regions,including the United States,Europe,and Japan,and analyzes cases of IIT-IST transitions.In conjunction with the development status of China's pharmaceutical industry and the current management of IIT,this paper examines the challenges faced in the transition from IIT to IST in China,and subsequently proposes relevant recommendations,aiming to better allocate clinical research resources for CGT products and promote the development of the CGT industry.
cell and gene therapyinvestigator-initiated trialindustry-sponsored clinical trialoverseas supervision systemsenlightenment
万方数据
维普
