FDA is upping efforts to incorporate real-world data in evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday participation in a partnership exploring how to use that data to improve testing quality, better inform population testing strategies
FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research.
Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used PCR-based diagnostics and serological antibody tests.
This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a potentially lasting and positive impact on the agency’s view of the utility of RWE to support – or even guide – drug approvals and labeling expansions beyond the context of the current public health emergency.
The FDA has joined a public-private diagnostic research project with the goal of bringing more real-world data to bear against the novel coronavirus, and gauging the accuracy of different kinds of tests.
Formed by the Reagan-Udall Foundation and Friends of Cancer Research, the COVID-19 Diagnostics Evidence Accelerator will work to collaborate with test manufacturers, technology companies and government and academic researchers, as well as professional societies, payers, and health systems.
A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID-19.
Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it can use real-world data and evidence for COVID-19 vaccine evaluation.
Real-world data is taking on a critical role in the age of COVID-19 drug development, where hasty authorizations are being made on limited datasets and natural history data is being collected in real time.
Teams across the industry have stepped up to adapt their data analysis tools to the crisis with the goal of applying previous learnings to benefit future patients. The challenge now will be scaling their systems to manage the unprecedented volume of patient data, while keeping pace with the evolving pandemic.
A manuscript detailing this study is under revision and awaiting acceptance by the British Journal of Clinical Pharmacology. The study was funded using an unrestricted grant from myTomorrows, a global company that connects patients to expanded access programs and helps drug companies collect data from these programs. Polak is a real-world data lead at myTomorrows.
