摘要
因缺乏专门的指导文件,中成药上市后临床有效性研究水平参差不齐,高质量证据不足,难以支撑政策决策、临床决策和产业决策的需求.针对这一现状,该项目在全国范围内召集临床医学、临床药学、循证医学、药物流行病学、医学伦理学,以及政策法规专家,参照国际药品上市后的研究模式,在我国相关法律法规和技术指导文件的框架下,充分考虑中成药自身特点以及我国国情,兼顾药品上市许可持有人、临床研究者、药品监管部门及药品使用者的多重视角,依据中华中医药学会团体标准的制定要求研制了《中成药上市后临床有效性研究指南》.全面贯彻全生命周期研究理念,强调中医药理论、人用经验和临床试验相结合,注重研究合规性、科学性、伦理性,从明确研究用途、分析药品特点、评估研究基础、提出临床定位、明确研究目的、实施分类研究6个步骤阐明了中成药上市后有效性研究的选题和决策路径,从设计类型、研究对象、样本量、疗效指标、偏倚、数据缺失、证据级别、实用性8个方面阐释了研究设计和实施的一般原则,并重点论述了证候中药及中药证候疗效评价研究、以临床价值为导向的效应机制研究、不同给药途径的中成药有效性研究的要点,为中成药上市后有效性研究提供通用的方法学指导.
Abstract
Due to the lack of specialized guidance,the post-marketing research on clinical effectiveness of Chinese patent medicines demonstrates varied quality and lacks high-quality evidence,failing to meet the demands of policy-making,clinical decision-making,and industrial decision-making.To address this issue,this project gathered experts in clinical medicine,clinical pharmacy,evidence-based medicine,drug epidemiology,medical ethics,and policy and regulation in China.They referred to the model of international post-marketing research on medicines and developed Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines under the framework of relevant laws and regulations and technical guidance documents in China.The guidelines were developed with consideration to the characteristics of Chinese patent medicines,China's national conditions,and all the stakeholders including marketing authorization holders,clinical researchers,drug administration,and users.The development of the guidelines followed the requirements for developing group standards set by the China Association of Chinese Medicine.The guidelines fully implement the concept of full life-cycle research,emphasizing the combination of traditional Chinese medicine(TCM)theory,human use experience,and clinical trials and pay attention to the compliance,scientificity,and ethics of research.The guidelines clarify the topic selection and decision-making path of the post-marketing research on effectiveness of Chinese patent medicines through six steps:determining research purpose,analyzing drug characteristics,evaluating research basis,proposing clinical orientation,clarifying research purpose,and implementing classified research.The general principles of research design and implementation were clarified from eight aspects:research type,research objects,sample size,efficacy indicators,bias,missing data,evidence level,and practicality.It focuses on the research on the TCM syndrome-based efficacy evaluation,clinical value-oriented mechanism of action,and the effectiveness of Chinese patent medicines with different routes of administration.The guidelines provide a universal methodological basis for the post-marketing research on clinical effectiveness of Chinese patent medicines.
维普
万方数据