临床研究中如何处理样本量的探索和报告?

S. Dwivedi
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引用次数: 0

摘要

无论研究设计如何,回答特定研究问题所需的最小样本量都是不可避免的,在随机对照试验中更为相关。在许多情况下,不需要样本量的探索,包括试点研究;它只是被认为是可行的或经验法则。然而,在某些情况下,包括像药物开发的第三和最后阶段这样的结论性研究,必须确保研究的最佳功效和信心水平。本文旨在用一种非统计语言解决与临床研究的样本量考虑相关的各种问题,重点是使医学研究人员易于理解。
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How to Deal with Sample Size Exploration and its reporting in Clinical Research?
The minimum sample size required to answer a specific research question is unavoidable regardlessof study designs, more pertinent in case of randomized controlled trials. Sample size exploration isnot required in many situations, including a pilot study; it is simply decided as feasible or a rule ofthumb. However, in situations, including a conclusive study like the third and final phase of drugdevelopment, it becomes mandatory to ensure optimal power as well as level of confidence to thestudy. The present write-up aims to address various issues related to sample size considerations forclinical studies in a non-statistical language, focusing on making it easily understandable by medicalresearchers.
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