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Updated: Sep 10, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

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第二阶段试验中的随机化:没有基于样本的大小的豁免

Theodor Framke1, Gernot Beutel2, Arnold Ganser2

  • 1Institute for Biostatistics, Hannover Medical School, Hannover, Germany.

British journal of clinical pharmacology
|August 27, 2025
PubMed
概括

单臂试验 (SAT) 似乎是可行的,但在药物开发中可能导致误导性结果. 随机临床试验 (RCT) 对于清晰的解释至关重要,即使是小组患者.

关键词:
洗钱/MDS 问题克洛法拉宾药物开发计划证据标准弗鲁达拉宾第二阶段随机化

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