The Therapeutics Evidence Accelerator is comprised of two interactive workstreams: the Evidence Accelerator Collaborative and the Parallel Analysis Workgroup.

Therapeutics Evidence Accelerator Collaborative

Interested data partners share findings on critical questions during Therapeutics Evidence Accelerator Lab Meetings. Results are generated and analyzed in many different ways and using different methods and data sources. Lab meetings provide a venue for scientists across the country to discuss data generated from quick turnaround queries and share results with peers and experts from FDA, major data organizations, academic research institutions, professional societies, and health systems to help accelerate, and potentially even confirm, findings from different data sources and leverage existing expertise. These meetings occur every Thursday from 3-4 pm ET. See Lab Meeting Summaries.

Nearly 120 organizations have participated in the Therapeutics Evidence Accelerator Collaborative meetings, including the following:

  • Aetion
  • APANDEMIC.ORG
  • Center for Medicine in the Public Interest
  • Ciox Real World Data
  • COTA
  • Datavant
  • Duke-Margolis Center for Health Policy
  • Flatiron Health
  • Health Catalyst
  • Health Verity
  • IQVIA
  • Johnson & Johnson
  • Lilly
  • Mayo Clinic
  • OHDSI
  • Panalgo
  • Pfizer
  • Roche
  • Sanofi
  • Syapse
  • Syntegra.io
  • TriNetX
  • UnitedHealth Group

Therapeutics Evidence Accelerator Parallel Analysis Workgroup

We worked closely with FDA to develop key research questions that multiple organizations and teams can address simultaneously. Initial activities of this work stream include (1) rapidly revising a list of core data elements; (2) identifying those critical to answering the primary question; and (3) establishing uniform collection parameters. It is necessary to work collaboratively to determine how data elements are being extracted and how they are being defined in order to operationalize a platform that can not only answer questions now, but also inform how research activities could be conducted in the future.

Repeating analyses in parallel by collaborators using different analytical techniques and data sources will help strengthen findings and learnings. Furthermore, this effort will help validate the role of real-world data as a tool for rapidly learning about patient characteristics, treatment patterns, and outcomes associated with management strategies for COVID-19.

The first question we are organizing around is around COVID-19 treatments. We sent an initial survey of critical questions and core data elements around, to which approximately 25 organizations responded with their data availability and feedback. Working with 8 organizations so far, we have since refined the definitions of these data elements, including inclusion, exclusion, exposure, and outcome definitions. These meetings occur every Wednesday from 12-1 pm ET.

Nearly 60 organizations have participated in the Therapeutic Evidence Accelerator Parallel Analysis Workgroup, including the following:

  • Aetion
  • Ciox Real World Data
  • COTA
  • Datavant
  • Duke-Margolis Center for Health Policy
  • Flatiron Health
  • Health Catalyst
  • Health Verity
  • IQVIA
  • Mayo Clinic
  • OHDSI
  • Roche
  • Syapse
  • TriNetX