：随着循证医学的兴起和推广，中医临床研究方案设计与过程管理质量显著提升。然而，目前临床研究的结局指标普遍存在不一致、不规范、不公认、随意性等问题，导致研究结果脱离临床决策需求、同类研究数据不能合并或比较分析、选择性报告偏倚等系列问题。建立相同病证研究必须报告的关键结局指标，即核心指标集（COS），规范结局指标的选择、测量与报告，可提高研究结果的实用性、可比性和透明度，使单个研究数据的价值得到充分利用。本研究以稳定型心绞痛中医临床试验核心指标集研究为载体，结合中医特点和国际最新研究成果，研究结局指标条目产生方法、指标域确定方法、核心指标条目遴选方法、核心指标一致性认定方法等，最终形成一套可资利用的中医临床试验核心指标集（COS-TCM）形成规范和方法学体系，从而引导各个专科病种能规范、高效地建立中医临床试验核心结局指标，进一步提升中医临床研究的质量以及结果的实用性和公认度。

Along with the development and widespread of Evidence-based medicine, the quality of clinical trials of Traditional Chinese Medicine (TCM) has rapidly improved, particularly in the protocol design and quality control during execution. However, there are several problems in outcome measures of clinical trials: inconsistent, non-standard, not recognized, arbitrariness, and other issues. These problems caused several serious problems for clinical trials: results is not valuable or not important for clinical practice or decision making; various outcome measures are impossible for combining or comparing results between different trials; selective reporting bias is uncontrollable. To establish imperative outcome measures for clinical trials of a certain condition,that is Core Outcome Sets (COS), can normalize the selection, measurement and reporting of outcome measures. As a consequence, the clinical significance, comparability and transparency will be impoved greatly. Meanwhile, the data of singal trial will be reused. This study aims to establish methods and processes for developing COS in TCM clinical trials, based on a pilot study for establishing COS for stable angina pectoris. The methodological system will be constructed by methods for developing items, deciding layer of items, selecting core outcoms, achieving consensus for COS, COS generalization and COS update. The methods and standard operation procedures generated from this study will be useful to guide each speciality of disease to develop COS for clincal trials of TCM (COS-TCM). Then, a series of COS-TCM for different diseases will be set up standardly and efficiently. Finally, the quality,practicality and recognization of clinical trials of TCM will be enhanced.