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.
摘要：
由于缺乏专门的指导,中成药临床疗效上市后研究质量参差不齐,缺乏高质量证据,不能满足决策的要求，临床决策,和工业决策。为了解决这个问题，这个项目聚集了临床医学专家，临床药学,循证医学,药物流行病学，医学伦理学,以及中国的政策和法规。他们参考了国际药品上市后研究的模式，在中国相关法律法规和技术指导文件的框架下，制定了中成药临床有效性上市后研究指南。该指南是考虑到中成药的特点而制定的,中国国情,以及所有利益相关者，包括营销授权持有人，临床研究人员，药物管理,和用户。该指南的制定遵循了中国中药协会制定的团体标准的要求。准则全面贯彻全生命周期研究的理念,强调中医（TCM）理论的结合，人类的使用经验，和临床试验，并注意依从性，科学性,和研究伦理。指南通过六个步骤明确了中成药上市后有效性研究的选题和决策路径:确定研究目的,分析药物特征，评估研究基础，提出临床方向，明确研究目的，实施分类研究。从八个方面阐明了研究设计和实施的一般原则：研究类型，研究对象,样本量,功效指标，偏见，缺少数据，证据水平,和实用性。重点研究中医证候疗效评价,以临床价值为导向的作用机制，以及不同给药途径的中成药的有效性。该指南为中成药临床疗效的上市后研究提供了普遍的方法学依据。
