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科学、规范的临床研究是考核预防用新生物制品安全性、有效性的唯一方法。明确疫苗临床研究的内容、制定合理客观的观察指标和判定标准、验证实验室测定方法、实施随机和盲法、选择适宜的受试人群、如实记录试验数据、科学的数据管理和统计学分析等是临床研究规范化的基础。本文尽可能全面的阐述临床研究规范化的各个方面 ,为新疫苗临床研究及制定我国预防用新生物制品临床研究指导原则提供参考。
Scientific and standardized clinical research is the only way to assess the safety and effectiveness of new biological products for prevention. Clear vaccine clinical research content, the development of objective and objective observation indicators and criteria, validation laboratory determination methods, the implementation of random and blind method, select the appropriate test population, truthfully record test data, scientific data management and statistical analysis Is the standardization of clinical research foundation. This article tries to expound all aspects of the standardization of clinical research as comprehensively as possible and provide references for the clinical research of new vaccines and the formulation of guidelines for the clinical research of new biological products for prevention in our country.