Department of Medicine, Section of Hematology/Oncology, University of Colorado, Aurora, CO, USA.
Blood. 2011 Feb 17;117(7):2089-92. doi: 10.1182/blood-2010-09-308858. Epub 2010 Nov 10.
Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process. Conventional academic steering committees are not provided with the independent infrastructure by which to verify statistical analyses and conclusions regarding safety and efficacy. We propose an alternative approach centered on partnerships between CROs and university-based academic research organizations (AROs). In this model, the ARO takes responsibility for processes that address journal requirements and regulatory expectations for independent academic oversight (including oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO provides infrastructure for efficient trial execution, site monitoring, and data management. The ARO engages academic experts throughout the trial process and minimizes conflicts of interest in individual industry relationships via diversification of sponsors, agents, and therapeutic areas. Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process.
近年来，临床试验设计、执行和发表的标准有所提高。然而，目前由制药赞助商为药物或设备开发项目提供资金、通常协助执行试验的合同研究组织（CRO）、监管机构和学者之间的互动结构，为开发过程提供的领导力和监督不足。传统的学术指导委员会没有提供独立的基础设施来验证安全性和疗效的统计分析和结论。我们提出了一种替代方法，以 CRO 和大学学术研究组织（ARO）之间的伙伴关系为中心。在这种模式下，ARO 负责满足期刊要求和监管机构对独立学术监督的期望的流程（包括对指导委员会和数据和安全监测委员会活动的监督），而 CRO 则提供高效的试验执行、现场监测和数据管理的基础设施。ARO 在整个试验过程中聘请学术专家，并通过赞助商、代理人和治疗领域的多样化，最大限度地减少个别行业关系中的利益冲突。尽管可以考虑许多模式，但 ARO-CRO 模式是专门为满足对临床试验完整性的更高保证的需求以及该过程中每个利益相关者的需求而构建的。
