篮式研究设计在中医药临床研究中的应用探索

Applied exploration of basket trial design in clinical research of traditional Chinese medicine

篮式研究设计是通过对具有同一特定分子靶标的多种疾病实施统一干预,以更小的患者群体和更短的试验时间需求获取较高效应的前瞻性临床研究方法,是母方案设计中的重要组成部分。篮式研究设计可有效提高临床研究效率,为难治性疾病临床研究的开展提供可能的条件。中医药临床研究或许可以借鉴本研究设计的思路和方法,以期提高中医药临床研究的效率,体现中医药的疗效优势。文章基于篮式研究设计的相关方法介绍,结合中医"以证统病、异病同治"的认知体系,对该设计在中医药临床研究中应用的可行性进行分析和展望,旨在为中医药临床研究提供新思路和新方法。

The basket trial design is a prospective clinical research method that achieves higher effects with a smaller patient population and shorter test time requirements by implementing a unified intervention on multiple diseases with the same specific molecular target, an important part of the master protocols. The basket trial design can effectively improve the efficiency of clinical research and provide possible conditions for the development of clinical research on refractory diseases. In the clinical research of traditional Chinese medicine(TCM), the ideas and methods of this trial design may be used to improve the efficiency of clinical research of TCM and reflect the advantages of TCM. This article is based on the introduction of the relevant methods of the basket trial design, combined with the TCM cognitive system of ‘syndromes dominate diseases, same treatments for different diseases’, to analyze and prospect the feasibility of the design in the clinical research of TCM. Research will provide new ideas and methods for the development of the clinical research of TCM.