Clinical trials are a fundamental component of medical research and serve as the main route to obtain evidence of the safety and efficacy of a treatment before its approval. A trial's ability to provide the intended evidence hinges on appropriate design, from background knowledge and trial rationale to sample size and interim monitoring rules. In this article, we present some general design principles for investigators and their research teams to consider when planning to conduct a trial.

中文翻译：

---

良好临床试验设计的原则

临床试验是医学研究的基本组成部分，是在获得批准前获取治疗安全性和有效性证据的主要途径。试验提供预期证据的能力取决于适当的设计，从背景知识和试验原理到样本量和临时监测规则。在本文中，我们提出了一些一般设计原则，供研究人员及其研究团队在计划进行试验时考虑。