Objective To study related guidelines such as“Guidelines for Clinical Trial Design of Oncolytic Viruses”“Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products”and“Technical Guidel...Objective To study related guidelines such as“Guidelines for Clinical Trial Design of Oncolytic Viruses”“Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products”and“Technical Guidelines for Pharmacological Research and Evaluation of Oncolytic Viruses(OVs)Products”issued by the Center for Drug Evaluation(CDE)on OV and offer some suggestions for further improvement of the policies and regulations.Methods Literature comparison and questionnaire survey were used in this paper to investigate the difficulties encountered in the practical work of domestic companies that have conducted clinical trials,thus drawing some lessons to help the subsequent implementation of the guidelines.Results and Conclusion According to the characteristics of specific varieties and the published laws,regulations and guidelines,companies can adopt more suitable and scientific strategies to accelerate the development of anti-cancer drugs.In the future,as more clinical studies and product development for various cancers expand,regulatory requirements are expected to become more specialized and complex.Learning from the regulatory experience of developed countries and regions,we can improve the regulatory system by adapting it to national conditions and development status of China.Additionally,some ideas and useful inspirations can be provided after reviewing the content of the relevant guidelines and the obstacles in the practice of corporate R&D process can be addressed.These efforts will facilitate the speed of R&D and allow enterprises to work more smoothly and efficiently.展开更多
文摘Objective To study related guidelines such as“Guidelines for Clinical Trial Design of Oncolytic Viruses”“Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products”and“Technical Guidelines for Pharmacological Research and Evaluation of Oncolytic Viruses(OVs)Products”issued by the Center for Drug Evaluation(CDE)on OV and offer some suggestions for further improvement of the policies and regulations.Methods Literature comparison and questionnaire survey were used in this paper to investigate the difficulties encountered in the practical work of domestic companies that have conducted clinical trials,thus drawing some lessons to help the subsequent implementation of the guidelines.Results and Conclusion According to the characteristics of specific varieties and the published laws,regulations and guidelines,companies can adopt more suitable and scientific strategies to accelerate the development of anti-cancer drugs.In the future,as more clinical studies and product development for various cancers expand,regulatory requirements are expected to become more specialized and complex.Learning from the regulatory experience of developed countries and regions,we can improve the regulatory system by adapting it to national conditions and development status of China.Additionally,some ideas and useful inspirations can be provided after reviewing the content of the relevant guidelines and the obstacles in the practice of corporate R&D process can be addressed.These efforts will facilitate the speed of R&D and allow enterprises to work more smoothly and efficiently.
