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.

When dealing with a cancer diagnosis, often times the best form of treatment can be offered through a clinical trial. We de-bunked common myths in a blog post, talking about the benefits of considering clinical trials, in efforts to shift the conversation from clinical trials being thought of as a “last option,” to figuring out if clinical trials may actually provide the best care and treatment you need.

FDA's Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens. Aetion's ability to perform consistent analyses across a variety of data sets was key for FDA in selecting the the partnership, which grew from Reagan-Udall Foundation and Friends of Cancer Research's Evidence Accelerator project.

Today, we are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions. The FDA and Aetion aim to answer questions about the use of diagnostics and medications in the pandemic, and risk factors for COVID-19-related complications in different patient populations.

The FDA said Tuesday it’s pairing up with the data company Aetion to research Covid-19 complications and what types of medicines virus patients are taking, which could help researchers learn more about which treatments are effective.

The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine — to learn more about Covid-19, including how diagnostics and medications are being used in the pandemic and how best to design studies to test them.

The project is a collaboration with Aetion, a New York health tech startup that specializes in real-world evidence.