Comparative and Translational Medicine Program, The Ohio State University College of Veterinary Medicine, Columbus, USA.
Columbia College of Veterinary Medicine, University of Missouri, Columbia, USA.
BMC Vet Res. 2021 Feb 25;17(1):90. doi: 10.1186/s12917-021-02795-z.
While a necessary step toward enhancing rigor and reproducibility of veterinary clinical trials conducted on the translational spectrum includes understanding the current state of the field, no broad assessment of existing veterinary clinical trial resources has been previously conducted. Funded by a CTSA One Health Alliance (COHA) pilot award, the goal of this project was to conduct an electronic survey of North American Veterinary Colleges regarding practices in veterinary clinical trial review, approval, conduct, and support in order to identify opportunities to leverage existing resources and develop new ones to enhance the impact of veterinary and translational health research.A total of 30 institutions were invited to participate in the survey and the survey response rate was 73 %. The most common source of funding noted for veterinary clinical research was industry (33 %); however, respondents reported that only 5 % (3.7-11.0) of studies were FDA-regulated. Respondents indicated that most studies (80 %); conducted at their institution were single site studies. Study review and approval involved the IACUC either solely, or in combination with a hospital review board, at 95.5 % of institutions. Workforce training related to clinical research best practices was variable across institutions. Opportunities were identified to strengthen infrastructure through harmonization of clinical research review and approval practices. This might naturally lead to expansion of multi-site studies. Based on respondent feedback, future workforce development initiatives might center on training in the specifics of conducting FDA-sponsored research, Good Clinical Practice (GCP), clinical study budget design, grants management, adverse event reporting, study monitoring and use of electronic data capture platforms.
虽然理解该领域的现状是提高兽医临床转化研究严谨性和可重复性的必要步骤，但之前尚未对现有的兽医临床研究资源进行广泛评估。本项目由 CTSA 一体健康联盟（COHA）试点奖资助，旨在对北美兽医学院进行电子调查，了解兽医临床研究审查、批准、进行和支持方面的实践情况，以确定利用现有资源和开发新资源的机会，从而提高兽医和转化健康研究的影响力。
共有 30 个机构受邀参与调查，调查回复率为 73%。兽医临床研究最常见的资金来源是行业（33%）；然而，受访者报告称，只有 5%（3.7-11.0）的研究受到 FDA 监管。受访者表示，他们所在机构进行的大多数研究（80%）都是单站点研究。95.5%的机构的研究审查和批准涉及 IACUC 或与医院审查委员会联合进行。与临床研究最佳实践相关的劳动力培训在各机构之间存在差异。通过协调临床研究审查和批准实践，有机会加强基础设施。这可能会自然导致多站点研究的扩展。根据受访者的反馈，未来的劳动力发展计划可能侧重于培训进行 FDA 资助研究、良好临床实践（GCP）、临床研究预算设计、项目管理、不良事件报告、研究监测和使用电子数据捕获平台的具体细节。
