2021 FDA Science Forum
Accelerating Evidence Generation by Convening Diverse Stakeholders Across the Real-World Data Ecosystem
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Contributing OfficeOffice of the Commissioner
Abstract
Background
In a situation with little historical data and a dearth of traditional information sources, the COVID-19 pandemic required learning about the disease in real-time, from disparate data sources, in a multi-pronged approach. In April 2020, the FDA Foundation, in collaboration with Friends and active participation by FDA and key stakeholders, launched the COVID-19 Evidence Accelerator. This model may be adapted to address other urgent public health challenges where collaborative scientific analyses using real-world data (RWD) could enhance understanding.
Purpose
The Accelerator brings together experts in health data aggregation and analytics in a collaborative effort to share insights, compare results and answer key questions. The Accelerator involves 200 organizations across the health data ecosystem: FDA, major health data/technology organizations, academia, professional societies, patient advocates, health systems, insurers, biopharma and medical device companies.
Methodology
Launching the Accelerator required: 1) generating core questions of relevance to FDA; 2) identifying RWD elements of potential applicability to those questions; 3) identifying groups who hold, or analyze, such data; 4) convening those groups to explore data strengths/ weaknesses; and 5) establishing a path to use data sources to address the generated questions. Early efforts focused on the natural history of COVID, related treatments, and the model expanded to diagnostic tests. Routine collaboration led to the emergence of a living textbook to capture RWD efforts and understanding, a forum for online interaction, and master protocols to explore similar questions.
Results
Beyond exploring discrete research questions of interest , the effort illuminated the benefit of RWD to complement clinical trials, created a roadmap to leverage RWD for productive analyses, began developing a common language for discussing FDA-relevant issues, and created the ability to identify the types of questions that can be answered by RWD.
Conclusion
The application of rigorous analytic methods to real-world datasets offers the opportunity to rapidly evaluate changes in practice, uptake of new therapies, and the understanding of the natural history of COVID and related sequalae. Beyond addressing questions of interest to FDA within COVID-19, the Accelerator model can be adapted for other public health and regulatory use cases, such as substance use disorders.
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- The Reagan-Udall Foundation for the FDA (the FDA Foundation) is a non-profit organization established by Congress with the sole purpose to advance the mission of the FDA. Friends of Cancer Research (Friends) is an advocacy organization that drives collaboration among partners in science, policy and regulation.
- See related abstract “The COVID-19 Evidence Accelerator – A Model for Advancing Real World Data and Evidence”.
