Clinical data collected outside of traditional clinical trials—also known as “Real-World Data” (RWD) — can provide insights to FDA on how COVID-19 treatments, diagnostics, and vaccines are performing in a variety of settings. The evidence generated depend on rigorous analytical methods as well as validation and cross-checking of analyses. The Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research and with active participation by FDA, launched the COVID-19 Evidence Accelerator.
The COVID-19 Evidence Accelerator brings together leading experts in health data aggregation and analytics in a unified, collaborative effort to share insights, compare results and answer key questions to inform the collective COVID-19 response. It provides a “collaborative space” for key players (nearly 200 organizations, to-date) across the health data ecosystem: FDA, major health data/technology organizations, academia, professional societies, health systems, insurers, drug and device industries, to assimilate and evaluate data generated from across the country.
Dedicated “parallel analyses” workstreams focused on therapeutics and diagnostics, data and analytics. Participants advanced methods to leverage RWD for actionable insights. Initial activities include (1) rapidly revising a list of core data elements; (2) identifying elements critical to answering the primary question; and (3) establishing uniform collection parameters. Three initial research areas (the use of hydroxychloroquine and azithromycin in hospitalized patients; the use of remdesivir; and the natural history of coagulopathy in COVID-19 patients) enabled establishing methodologies and processes for creating common data elements and interoperability. The comparable effort in Diagnostics explores the use of molecular and antibody tests.
A critical early result of the Evidence Accelerator has been the characterization of the natural clinical history of COVID-19 in hospitalized patients—foundational to ensuring testing performance, identifying treatment, predicting immunity, detecting potential for future waves of infection, and tracking mutation.
Real World Evidence (RWE) may help regulators and scientists augment information received in randomized clinical trials by shared insight, common research questions, innovative use of parallel analysis, rapid queries and lab meetings. The Evidence Accelerator creates a strong foundation for rapid collection and rigorous analysis of RWD to answer urgent questions about COVID-19.