WHEN YOU DON’T QUALIFY FOR A CLINICAL TRIAL: EXPANDED ACCESS MIGHT HELP - Triage Cancer

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 this 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.

Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets - Pinksheet

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.

Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

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.

FDA, partnering with New York health tech firm, seeks to collect ‘real-world’ data on Covid-19 - STAT

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.

BioCentury This Week: Special Edition - Getting Real about COVID-19 Data

Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, described in podcast interviews with BioCentury’s Washington Editor Steve Usdin how the pandemic has accelerated progress on integrating real-world data and evidence into research and practice.

Health, Defense Agencies Should Cooperate to Beat COVID-19 - RealClearHealth

The U.S. has been trying to contain COVID-19 through testing and social distancing. Now it’s time to kill it.

What’s needed is intragovernmental cooperation, something that, sadly, is rare in the nation’s capital. In this case, Congress and the Trump Administration should empower agencies that don’t traditionally work closely together to join forces: The Food and Drug Administration (FDA) and DARPA (the Defense Advanced Research Projects Agency) in the Department of Defense. The FDA knows the enemy and DARPA has the logistical know-how to strike quickly.

 

Beyond the Magic Bullet: Medical Progress Is Often Incremental - National Review

Life won’t completely return to normal while the novel coronavirus remains a threat to health and to life. More than 60,000 Americans have already lost their lives to this virus; while older people seem especially vulnerable, the virus has demonstrated its ability to kill people of all ages. Even as the country edges back to work and school, there’s a palpable anxiety. We don’t want to get infected, and we don’t want to infect others.

Accelerating the collection of real-world data about COVID-19 - Biocentury

The Reagan-Udall Foundation and Friends of Cancer Research are trying to put real-world data to use against COVID-19.

If there are silver linings to the COVID-19 crisis, one is the way groups and individuals who often have adversarial or competitive relationships are joining together to fight a common threat. Another is the acceleration of science and medicine that comes from overcoming barriers that have slowed progress.

Read more.