Experiences of establishing an academic early phase clinical trials unit
Experiences of establishing an academic early phase clinical trials unit
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DOI：
10.1177/1740774517710250
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发表时间：
2017-08-01
期刊：
影响因子：
2.7
通讯作者：
Flanagan, Louise
中科院分区：
文献类型：
--
作者：
Brown, Sarah R.;Sherratt, Debbie;Flanagan, Louise
背景：早期阶段试验在药物开发中至关重要，确定适当的剂量水平和评估初步活性。这些试验由工业界和学术界进行，两者之间的合作日益增加。我们面临着快速、安全、有力地进行这些试验的压力。然而，与后期药物试验相比，开发和管理早期阶段药物试验之间存在内在差异。本文描述了一种建立以学术为主导的早期试验组合的方法，突出了吸取的教训和分享经验。方法：2009年，利兹大学临床试验研究部门成为英国骨髓瘤I期和II期临床试验协调办公室。我们开始从第三阶段的广泛工作过渡到早期阶段的试验开发和实施。这包括评估和修改我们建立的标准操作程序，访问其他学术早期单位，并开发必要的新文件和流程。结果：建立了一个由试验和数据管理人员以及统计人员组成的核心团队，以促进专业知识和知识的保留。实施了详细的培训计划，重点是早期阶段的基本标准实践。这些包括药物警戒、招募、试验设计和设置、数据和现场监测以及监督委员会。纳入了早期试验统计方法的培训。结论：早期试验管理和行为的初步范围对建立早期组合至关重要。开发的许多流程都是成功的。但是，实施了定期审查和评估，以实现变更并确保效率。建议其他人在本文中描述的经验的基础上进行这项冒险。
Background: Early phase trials are essential in drug development, determining appropriate dose levels and assessing preliminary activity. These trials are undertaken by industry and academia, with increasing collaborations between the two. There is pressure to perform these trials quickly, safely, and robustly. However, there are inherent differences between developing and managing early phase, compared to late phase, drug trials. This article describes an approach to establishing an academically led early phase trial portfolio, highlighting lessons learned and sharing experiences.Methods: In 2009, the University of Leeds Clinical Trials Research Unit became the Clinical Trials Coordinating Office for Myeloma UK's phase I and II trials. We embarked on a transition from working extensively in phase III to early phase trials development and conduct. This involved evaluating and revising our well-established standard operating procedures, visiting other academic early phase units, and developing essential new documentation and processes.Results: A core team of trial and data managers and statisticians was established to facilitate expertise and knowledge retention. A detailed training plan was implemented focussing on essential standard practices for early phase. These included pharmacovigilance, recruitment, trial design and set-up, data and site monitoring, and oversight committees. Training in statistical methods for early phase trials was incorporated.Conclusion: Initial scoping of early phase trial management and conduct was essential in establishing this early phase portfolio. Many of the processes developed were successful. However, regular review and evaluation were implemented to enable changes and ensure efficiencies. It is recommended that others embarking on this venture build on the experiences described in this article.