临床试验设计:简化概述

Pranali M. Wandile
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引用次数: 0

摘要

临床试验的目的是发明新的、更好的、更安全的、更有效的方法来预防、检测或治疗健康状况,并将其与现有的适用护理标准进行比较。这种科学调查促使研究人员设计和制定拟议的临床试验方案,以评估有关产品的初步信息,并制定研究问题和目标。新产品开发的平均预算是巨大的,这种可能性是因为几乎90%的试验药物从未获得批准。因此,有一个适当的临床试验设计是成功的产品开发的关键。试验提供建议适应症的能力取决于其适当的设计、背景信息、试验对样本量的论证、临时监测规则以及审查和分析研究数据的方法。在这篇文章中,我们介绍了临床试验设计的概述,强调以一种简化的方式为现场临床研究专业人员提供适应性设计。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical trial designs: a simplified overview
Clinical trials aim to invent new, better, safer, more effective ways to prevent, detect, or treat health conditions and to compare them to existing standards of care as applicable. This scientific inquiry prompts researchers to design and develop proposed clinical trial protocols to evaluate preliminary information about the product and develop research questions and objectives. The average budget for new product development is enormous, and this eventuality is because almost 90 percent of a trial drugs never get approved. Hence, having an appropriate clinical trial design is crucial for successful product development. A trial's ability to deliver the proposed indication relies on its suitable design, background information, the trial justification to sample size, interim monitoring rules, and ways to review and analyze study data. In this article, we presented an overview of clinical trial designs emphasizing adaptive designs in a simplified way for field-based clinical research professionals.
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