临床研究设计方案要点之临床试验方案设计的几点思考

Key point of clinical research protocol design-ponders on design clinical trial protocol

临床试验方案是开展临床试验时不可或缺的关键点,主要包括医学、伦理、统计和试验管理四个方面的设计。设计一份合适的临床试验方案在开展临床试验的过程中至关重要,科学、详尽、清晰的临床试验方案是保证临床试验取得成功并能保证其科学性、可靠性和准确性。本文结合临床试验方案设计的准则和本团队多年来的实践心得,对临床试验方案设计中几个容易出现考虑纰漏或疑惑的方面进行了简要分析,以期为临床试验方案设计提供参考。

The clinical trial protocol is a indispensable element for performing clinical trials, it major contains medical design, ethics design, statistics design, and trial management design. Designing a suitable protocol is very important for performing the clinical trial, because a scientific, detailed, and clear protocol can ensure the trial come to success and ensure the scientificity, reliability, and accuracy of the trial. In this article, we analyzed and introduced the some points which is easy occur careless mistake or puzzled based on the principle of design clinical trial protocol and our practical experience, in order to provide some references for design clinical trial protocol.