Real world data (RWD) can help advance our nation’s ability to respond to the COVID-19 global pandemic by significantly informing and safely speeding diagnostic and therapeutic processes. At FDA’s request, the Reagan-Udall Foundation for the FDA (the Foundation), in collaboration with Friends of Cancer Research (Friends), launched the COVID-19 Evidence Accelerator. The model for the Evidence Accelerator's groundbreaking work is built on each organization's strengths: the Foundation's post-market safety surveillance through its Innovation in Medical Evidence Development and Surveillance (IMEDS) public-private partnership and Friends' pioneering use of “parallel analysis” to explore how real-world endpoints can rapidly address clinically relevant questions about treatment effectiveness.

Urgency and Action: Since the beginning of the pandemic, data scientists around the country have engaged in an intense effort to capture real-world data and rapidly deploy data analytics to help answer key questions related to the management of COVID-19 patients. While these individual efforts are developing into valuable insights, by banding together we are collectively accelerating and maximizing the utility of this information. To do this effectively, a core set of common data elements have been developed that allow any willing data collection effort to embed these data elements into their on-going work in a uniform way to allow for rapid aggregation and analysis.

An overview of the COVID-19 Evidence Accelerator was presented at the Spring 2021 FDA Science Forum. Please view the poster below. For more information, please visit FDA's website.

Accelerating Evidence Generation by Convening Diverse Stakeholders Across the Real-World Data Ecosystem
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COVID-19 Evidence Accelerator Principles

Download the PDF here