Caroff Krissa, Davey Victoria J, Smyth Miriam, Huang Grant D
Office of Research and Development, Department of Veterans Affairs, Washington, DC.
Fed Pract. 2023 Nov;40(11 Suppl 5):S18-S22. doi: 10.12788/fp.0415. Epub 2023 Nov 1.
The US Department of Veterans Affairs (VA) Office of Research and Development (ORD) supports an extensive clinical trials enterprise. Until recently, external partnerships were limited. The VA's potential value as a partner became more apparent during the COVID-19 pandemic because of its large health care system, diverse patient population, and expertise in conducting clinical trials.
By leveraging its infrastructure, the VA was able to participate in 7 large-scale COVID-19 therapeutic and vaccine trials. A key aspect of this enterprise approach is the ability to provide centralized direction and coordination. The VA's partnerships with external groups offered insights into the challenges associated with conducting important trials, especially when rapidity and coordination were essential. The ORD also developed solutions for reducing study startup time that could be established as best practices. We offer lessons for the challenges VA faced: site infrastructure needs and capabilities; study management roles and responsibilities; educational resources; local review; study design demands; contracting and budgeting; central-level systems; and communication.
VA participation in major COVID-19 therapeutic and vaccine trials represented a significant part of its research response to the pandemic. These contributions extended beyond the participants, scientists, and data that helped inform subsequent regulatory approvals. The VA also had an opportunity to directly develop partnerships with non-VA groups. These groups became more familiar with the VA while enabling us to gain more experience in the diverse practices used to conduct multisite clinical studies. Ultimately, these efforts empower the VA to further serve the broader scientific and clinical communities.
美国退伍军人事务部（VA）研发办公室（ORD）支持广泛的临床试验事业。直到最近，外部合作还很有限。由于其庞大的医疗保健系统、多样化的患者群体以及开展临床试验的专业知识，VA作为合作伙伴的潜在价值在新冠疫情期间变得更加明显。
通过利用其基础设施，VA能够参与7项大规模的新冠治疗和疫苗试验。这种企业方法的一个关键方面是能够提供集中指导和协调。VA与外部团体的合作提供了对开展重要试验相关挑战的见解，特别是在速度和协调至关重要的时候。ORD还开发了减少研究启动时间的解决方案，这些方案可确立为最佳实践。我们针对VA面临的挑战提供经验教训：现场基础设施需求和能力；研究管理角色和职责；教育资源；本地审查；研究设计要求；合同和预算；中央层面系统；以及沟通。
VA参与重大新冠治疗和疫苗试验是其对疫情研究应对措施的重要组成部分。这些贡献不仅限于参与者、科学家和有助于为后续监管批准提供信息的数据。VA还有机会直接与非VA团体建立合作关系。这些团体对VA更加熟悉，同时使我们在用于开展多中心临床研究的各种实践中获得了更多经验。最终，这些努力使VA能够进一步服务更广泛的科学和临床社区。
