The Real-World Performance of In Vitro Diagnostics

Advancing opportunities in real-world data and real-world evidence is critical to address the evolving health needs created by the COVID-19 pandemic. To further that work, the FDA Foundation is pleased to embark on an exciting program to evaluate the Real-World Performance of In Vitro Diagnostics (PIVD).

A Community of “Accelerators”

In June of 2021, the Therapeutics Parallel Analysis (TxPA) work group of the COVID-19 Evidence Accelerator paused to conduct a retrospective or “retro”. For those of you who are unfamiliar with the expression, a retro is an opportunity to review the work of a previous cycle or “sprint” in Agile terminology. A retro allows the Evidence Accelerator community the opportunity to step back and see how far we have come, what went well, and where we could make improvements.

Race and COVID-19: Where do we go from here?

COVID-19 exposed significant racial and ethnic health inequities in our U.S. health system. The current pandemic demonstrates the structural challenges we must overcome as health professionals to ensure equitable access to health-promoting services and the role data collection can play.

Working Toward Data Interoperability

When talking about data interoperability, researchers should understand that most data issues can be traced back to a lack of alignment.

Evidence Accelerator Model – A Critical Catalyst Towards A Learning Health System

Our national and global shared experience with COVID-19 crystallized the criticality of near real-time, real-world data (RWD) to generate insights and actionable information; and the imperative to drive towards a learning health system.

Guidance on Evaluating Impact of Viral Mutations on COVID-19 Tests and Lessons Learned Thus Far

As part of our March 18 COVID-19 Diagnostics Evidence Accelerator Collaborative meeting, Dr. Timothy Stenzel, Director of FDA’s Office of In Vitro Diagnostics and Radiological Health detailed the impact of viral mutations on COVID-19 testing and answered key questions posed by meeting participants.

COVID-19 Evidence Accelerator workgroup to coordinate medication use definitions across Evidence Accelerator data partners

During a recent COVID-19 Evidence Accelerator (EvAcc) Therapeutics Parallel Analysis meeting¹ we saw the synergy and creativity that arises when multiple partners work on the same data challenges.

Putting Our Heads Together