Principles of Good Clinical Trial Design.
2020
Abstract 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.
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