如何开展高质量临床研究

How to carry out high quality clinical trial

以高质量的大型临床研究结果为依据的循证医学思维逐渐被广大临床医生接受，因此大型医疗机构的临床医生主导或参与临床研究的积极性空前高涨。然而，如何提高大型临床研究的研究质量和管理水平，使其结果得到国际认可是我们面临的巨大挑战。本文从目前国内多数大型医疗机构面临的困境以及研究模式转变所提供的发展空间切入，提出开展高质量临床研究需要做到密切关注学科领域的发展、培养临床科研的思维．保证科学严谨的设计，规范每个操作环节的实施步骤和细节，以及建立一支分工协作、沟通通畅的团队等方面来提高研究质量。当前我国的诊疗规范和疾病指南里鲜有国人的数据支持，我们应根据实际情况来科学地制定设计研究方案并严谨执行，为制定适合我国疾病特征的诊疗指南提供高级别的证据。

Evidence-based medicine derived from large -scale clinical trials has been widely accepted by clinicians, which strongly motivates the clinicians in medical institutions to eonduct or participate in clinical trials. However, how to improve the clinical trial quality and management to achieve worldwide aceeptanee still remains challenging. By analyzing the difficulties faced by the majority of large Chinese clinical institutions and the opportunities during the evolvement of research modes, this paper proposes to improve the quality of clinical trial by closely following the domain development, raising clinical research thinking, ensuring rigorous research design, standardizing the steps and details of each operational session, as well as establishing a collaborative and well- communicated team. So far there is limited data support in therapeutic standards and guidelines in China. We have systematically designed and r/go^usly operated the research program based on the actual situation, whereby we have derived a set of high-quality disease guidelines that are adapted to the national disease characteristics in China.