Comparative Oncology Trials Consortium

COP的核心组成部分是比较肿瘤学试验联盟（NCI- cotc），该联盟是一个基础设施，将制药和生物技术公司等研究发起人与北美22个学术兽医中心联合起来，支持研究性治疗的多中心临床试验，其中NCI提供集中试验支持和数据管理。这种临床试验基础设施支持将患有癌症的宠物狗纳入新的癌症药物的开发路径。COTC与其他NCI调查人员、学术机构和/或制药行业合作开展宠物动物试验。这些试验是通过财团成员的集体工作量来实施的，COTC成员机构通过单一的谅解备忘录（MOU）联合起来。这些试验通常规模较小，并侧重于与药物开发相关的相关生物学终点。宠物动物试验旨在回答有关药物特性的具体问题，并且结果将由申办者迅速整合到新治疗剂的开发计划中。通过这些研究产生的数据可供COTC成员使用，以促进更大规模的研究者发起的宠物动物试验，这可能进一步补充这一转化过程。缔约方会议负责领导、监督和管理审判工作。试验赞助者，通常是制药公司，支持COTC进行的研究的临床费用。这种支持由发起人通过集体定义的合同直接支付给COTC中心，并且这一过程已经简化，因此不会对试验造成障碍。一项要求是，与人类药物开发有关的科学问题必须在议定书中明确和清楚地说明。由于缔约方会议的独特定位，这些问题的框架通常由缔约方会议指导，因为许多外部调查员不熟悉这一过程。COTC进行的试验旨在包括临床和生物学终点，即药代动力学和药效学，以便为早期人体试验的设计提供最佳信息，并协助早期和后期人体试验之间的困难过渡。试验启动和科学发展的过程由缔约方会议领导，但涉及与试验发起人和COTC研究人员进行详细和反复的讨论。现有的用于在COTC内实施试验的基础设施是针对CCR内的现有结构加以利用的。例如，我们与Jeff Shilling/Pamela Asangong （CCR）合作，维护CCR的C3D （Oracle临床）数据报告系统的“狗友好”版本。这允许COTC研究者和发起人根据良好临床实践（GCP）进行实时数据输入和审查，完全类似于人体试验中使用的形式。这使赞助商能够快速评估研究结果并在FDA提交中使用它们。第一个完成的COTC试验于2009年发表，第24个试验概念目前正在开放登记。我们的试验方案说明了COTC研究的细节和科学严谨性。我们的开放式试验方案示例见第V节/临床方案摘要。尽管比较肿瘤学领域取得了进展，但在自然发生癌症并与人类癌症有强烈相似性的大型动物身上评估新疗法的概念仍然被认为是新颖的。该领域的一个重要需求是将这一机会、其风险和潜在回报呈现给各种利益相关者，尤其是制药公司。并非所有问题都应该或可以通过这种方法提出，因此缔约方会议在提供对这些资源的管理方面发挥着重要作用。这些专业知识最近以《临床癌症研究》的一篇观点文章的形式传播开来，讨论了比较肿瘤学研究的问题和相关价值

The core component of the COP is the Comparative Oncology Trials Consortium (NCI-COTC), which is an infrastructure uniting study sponsors, such as pharmaceutical and biotechnology companies, with 22 academic veterinary centers within North America to support multicenter clinical trials of investigational therapeutics, wherein centralized trial support and data management is provided by the NCI. This clinical trial infrastructure supports the integration of pet dogs with cancer into the development path of new cancer drugs. The COTC initiates pet animal trials in collaboration with other NCI investigators, academic institutions and/or the pharmaceutical industry. These trials are implemented through the collective caseloads of the consortium membership with COTC member institutions united through a single Memorandum of Understanding (MOU). These trials are typically small and focused on relevant biological endpoints associated with drug development. The pet animal trials are intended to answer specific questions regarding the properties of a drug and results are to be rapidly integrated into the development plans for novel therapeutic agents by the sponsor. The data generated through these studies are available to COTC members to facilitate larger investigator-initiated pet animal trials that may further complement this translational process. The COP provides leadership, oversight, and management of trials. Trial sponsors, most often pharmaceutical companies, support the clinical costs of studies conducted by the COTC. This support is paid directly to COTC centers by the sponsor through collectively defined contracts, and this process has been streamlined so as to not create a barrier to the trial. A requirement is that the scientific question related to human drug development must be explicitly and clearly stated in the protocol. Due to the unique positioning of the COP, the framework of these questions is usually guided by the COP as many outside investigators are unfamiliar with this process. Trials conducted by the COTC are designed to include clinical and biological endpoints, i.e. pharmacokinetics and pharmacodynamics, so as to optimally inform the design of early phase human trials and assist in the difficult transitions between early and later phase human trials. The process of trial initiation and scientific development is led by the COP but involves detailed and iterative discussions with the trial sponsor and COTC investigators. The infrastructure that exists to implement trials within the COTC is leveraged against existing structures within the CCR. For example, in collaboration with Jeff Shilling/Pamela Asangong (CCR), we maintain a "dog friendly" version of the CCR's C3D (Oracle Clinical) data reporting system. This allows real-time data entry and review under Good Clinical Practice (GCP) by COTC investigators and sponsors exactly analogous to the forms used in human trials. This enables sponsors to quickly assess study results and use them in FDA submissions. The first completed COTC trial was published in 2009 and the 24th trial concept is currently open for enrollment. The detail and scientific rigor mandated for COTC studies is exemplified in our trial protocols. Examples of our open trial protocols are provided under Section V/Clinical Protocol Summary. Despite the progress made in the field of comparative oncology, the concept of evaluating new therapeutics in large animals that naturally develop cancer and share strong similarities to human cancers is still considered novel. A significant need in the field is to present this opportunity, its risks, and potential rewards to various stakeholders, not least of which is Pharma. Not all questions should or can be asked through this approach and thus COP plays an important role in providing stewardship over these resources. This expertise has recently been disseminated in the form of a Perspectives piece in Clinical Cancer Research addressing the questions and associated value of comparative oncology studies