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

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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.