The COVID-19 crisis has fast-tracked long-contemplated, patient-centric changes in medicine.
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.
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.
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.
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.
Document Drawer
The Reagan-Udall Foundation for the FDA and Friends of Cancer Research launched the COVID-19 Evidence Accelerator, a public-private partnership to use data analytics to understand the virus.
"Identifying key questions and core data elements is at the heart of a new initiative launched by the Reagan-Udall Foundation and Friends of Cancer Research.
The COVID-19 Evidence Accelerator provides a venue for major data organizations, government and academic researchers, and health systems to gather and design queries that can be quickly turned around and their results shared.
"A new initiative called the COVID-19 Evidence Accelerator aims to pool ongoing data sources from government and academic researchers, health systems, and private companies to solut
"Patients with cancer are treated with drugs already approved by the U.S. Food and Drug Administration (FDA) or with an investigational agent in a clinical trial. But there are some patients who may need access to investigational drugs outside the realm of a clinical trial..."
Read more about how Project Faciliate and the Foundation are working together to simplify the expanded access process: http://obroncology.com/article/fda-eases-access-to-unapproved-cancer-drugs/
The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting.
Project Facilitate is essentially a call center that will be run by the FDA Oncology Center of Excellence. It’s a single point of contact where FDA oncology staff will help oncology providers submit an expanded access request for an individual patient.
