SPARC: Supporting Patient Access, Real-world data, and critical Collaborations

SPARC：支持患者访问、真实数据和关键协作

• 批准号: 10705038
• 负责人: Amarnath Bhat
• 金额: $ 151.6万
• 依托单位: REAGAN-UDALL FOUNDATION/FOOD/DRUG/ADMIN
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-20 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705038
• 关键词: SPARC; Supporting; Patient; Access; Real

Effective engagement with the public is essential to expand the impact of the U.S. Food and Drug Administration, and for the efficient transfer of information and insights among the agency, patients, academia, consumers and regulated industry. Through “SPARC: Supporting Patient Access, Real-world evidence, and critical Collaborations”, the Reagan-Udall Foundation for the FDA will expand our activities that enable critical public health collaborations among FDA, industry, and the public. As specifically intended by Congress, we will identify unmet regulatory science needs and support projects and programs that promote the use of the latest in biomedical research and development to modernize product development, accelerate innovation, and enhance product safety. SPARC has three Specific Aims: 1) Supporting Real-World Data and Evidence; 2) Enhancing Access to Investigational Medications; and 3) Partnerships to Enhance Nutrition Education & Food Safety. In Aim 1, the Foundation will develop a real-world data consortium to serve as a platform to evaluate and conduct algorithm validation studies and to validate claims-based algorithms for high priority health outcomes. In addition, the Foundation will convene diverse stakeholders invested in using real-world data to share findings and lessons learned through the COVID-19 Evidence Accelerator platform The Evidence Accelerator will help to characterize the natural history of COVID-19 and generate evidence related to the safety and effectiveness of COVID-19 therapeutics. In Aim 2, the Foundation will leverage its expertise and experience in expanded access and patient engagement to increase awareness and assist prescribers and patients in the often- confusing process of applying for expanded access. A new Expanded Access Application Submission Portal will be integrated into the Foundation’s Expanded Access Navigator to simplify the processing of requests by FDA staff. New user guides and toolkits for healthcare providers and patients will be developed and disseminated through our stakeholder network. Finally, in Aim 3, we will use our expertise in convening diverse groups to develop a partnership to create new opportunities for FDA and food stakeholders to share perspectives and collaborate on important issues related to nutrition and food safety. As a first activity, the partnership will focus on building an education campaign to promote the use and understanding of the revised Nutrition Facts Label.

与公众的有效接触对于扩大美国粮食和农业的影响至关重要 药品监督管理局，并在该机构之间有效地传递信息和见解， 患者、学术界、消费者和受监管的行业。通过“SPARC：支持患者” 访问、真实世界证据和关键合作“，里根-尤德尔基金会 FDA将扩大我们的活动，使FDA之间能够进行关键的公共卫生合作， 行业和公众。按照国会的具体意图，我们将确定未得到满足的监管 科学需要并支持促进使用最新技术的项目和方案 生物医药研发实现产品开发现代化，加速 创新，提升产品安全。 SPARC有三个具体目标：1)支持真实世界的数据和证据；2)加强 获得研究药物；以及3)加强营养教育和伙伴关系 食品安全。 在目标1中，基金会将发展一个真实世界数据联盟，作为一个平台 评估和执行算法验证研究，并验证基于索赔的算法 高度优先的健康结果。此外，基金会将召集不同的利益攸关方 投资于使用真实世界的数据通过新冠肺炎分享调查结果和经验教训 证据加速器平台证据加速器将有助于表征自然 新冠肺炎的历史，并生成与新冠肺炎的安全性和有效性相关的证据 治疗学。 在目标2中，基金会将利用其在扩大准入和 患者参与，以提高认识，并帮助处方医生和患者- 申请扩大准入的程序令人困惑。一种新的扩展访问应用 提交门户将集成到基金会的扩展访问导航器中，以 简化FDA工作人员对请求的处理。新的医疗保健用户指南和工具包 提供者和患者将通过我们的利益相关者网络得到发展和传播。 最后，在目标3中，我们将利用我们的专业知识召集不同的团体来发展伙伴关系 为FDA和食品利益相关者创造新的机会，分享观点和 在与营养和食品安全相关的重要问题上进行合作。作为第一项活动， 伙伴关系将侧重于建立一项教育活动，以促进使用和理解 修订后的营养事实标签。