Herfarth Hans H, Jackson Susan, Schliebe Barbara G, Martin Christopher, Ivanova Anastasia, Anton Kristen, Sandler Robert S, Long Millie D, Isaacs Kim L, Osterman Mark T, Sands Bruce E, Higgins Peter D, Lewis James D
*Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina; †CGIBD Biostatistics Core, University of North Carolina, Chapel Hill, North Carolina; ‡Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; §Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; ‖Division of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania; ¶Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; #Division of Gastroenterology and Hepatology, Michigan, Indiana; and **Center for Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.
Inflamm Bowel Dis. 2017 Jan;23(1):14-22. doi: 10.1097/MIB.0000000000000907.
Investigator-initiated randomized clinical trials are the backbone of academic clinical research. Investigator-initiated trials (IITs) complement the large clinical studies sponsored by industry and address questions, which are usually not the main focus of a commercially directed research but have the purpose to confirm, improve, or refute clinically important questions with regard to diagnostic and therapeutic approaches in patient care. The aim of this review is to illustrate the necessary steps to start and complete an IIT in the field of inflammatory bowel diseases in the United States. The initial milestones for an investigator include structuring a protocol, planning and building of the trial infrastructure, accurately estimating the costs of the trial, and gauging the time span for recruitment. Once the trial has begun it is important to keep patient recruitment on target, monitor of the data quality, and document treatment emergent adverse events. This article provides a framework for the different phases of an IIT and outlines potential hurdles, which could hinder a successful execution.
研究者发起的随机临床试验是学术临床研究的支柱。研究者发起的试验（IIT）补充了由行业赞助的大型临床研究，并解决了一些问题，这些问题通常不是商业导向研究的主要重点，但其目的是确认、改进或反驳关于患者护理中诊断和治疗方法的临床重要问题。本综述的目的是阐述在美国炎症性肠病领域启动和完成一项IIT的必要步骤。研究者的初始里程碑包括制定方案、规划和构建试验基础设施、准确估算试验成本以及评估招募的时间跨度。一旦试验开始，重要的是使患者招募达到目标、监测数据质量并记录治疗中出现的不良事件。本文提供了一个IIT不同阶段的框架，并概述了可能阻碍成功实施的潜在障碍。
