Frumkin Lyn
School of Medicine, SPARK at Stanford, Stanford University, Stanford, California, USA.
Clin Transl Sci. 2025 May;18(5):e70237. doi: 10.1111/cts.70237.
Clinical trials with investigator sponsors at academic sites have increased, in part due to studies involving drug repurposing, the process of identifying new uses for existing drugs that are initially conducted in patients rather than healthy participants. In contrast to industry- or government-sponsored trials, investigator-sponsored clinical studies, also known as investigator-initiated trials, are typically conducted at one or several academic centers and are resource-limited by finances and patient numbers. These studies can serve as crucial pilot studies to inform the design of larger, more definitive clinical trials. Drawing from the experience of working with clinical researchers in academic settings, this tutorial presents guidelines for writing clinical protocols for resource-limited investigator-sponsored studies that meet international standards and optimize the detection of meaningful signals or outcomes that can lead to investigation in larger well-controlled trials.
学术机构中由研究者发起的临床试验有所增加，部分原因是涉及药物重新利用的研究，即确定现有药物新用途的过程，这类研究最初是在患者而非健康受试者中进行的。与行业或政府资助的试验不同，研究者发起的临床研究，也称为研究者启动的试验，通常在一个或几个学术中心进行，并且在资金和患者数量方面资源有限。这些研究可以作为关键的先导研究，为设计更大、更具确定性的临床试验提供信息。借鉴在学术环境中与临床研究人员合作的经验，本教程提出了为资源有限的研究者发起的研究撰写临床方案的指南，这些方案要符合国际标准，并优化对有意义信号或结果的检测，从而能够在更大规模的严格对照试验中进行研究。
