Some thoughts on the construction and development of somatic cell clinical research initiated by hospital researchers during the"14th Five-Year Plan"
Based on the spirit of guidance document of China's"14th Five-Year Plan"for the Development of the Bioeconomy and the latest Guidelines for Somatic Cell Clinical Research(Trial),and combined with the current situation and development trend of clinical research initiated by hospital investigators at home and abroad,this paper analyzes the advantages and disadvantages of investigator initiated trial of somatic cell in the transformation of cell therapy-related technology products and clinical application.To explore the future development of investigator initiated trial of somatic cell.Relevant hospitals should standard the Guidelines for Somatic Cell Clinical Research(Trial),establish a somatic cell technology evaluation and mutual selection system,establish a platform for somatic cell preparation production and testing and release,establish a platform for pre-clinical and clinical contract research organization optimization,and establish a platform for clinical data and standardized management by combining the relevant disciplines of their respective hospitals and joint regional characteristic resources,so as to jointly promote the high-quality development of somatic cell clinical research initiated by Chinese researchers.
Investigator initiated trialSomatic cellStandardized managementHigh-quality development
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