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一个有前途的生物标志物适应性2/3期设计 - 解释和扩展

Cong Chen1, Linda Sun1, Xuekui Zhang2

  • 1Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, NJ 07065, USA.

Contemporary clinical trials communications
|November 30, 2023
PubMed
概括

本研究引入了针对瘤学药物的适应性2/3期临床试验设计. 它允许基于临时生物标志物分析的灵活进展,优化药物开发途径,同时保持统计完整性.

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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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