On June 18, 2020, the U.S. Food and Drug Administration (FDA) took an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA announced its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics…
As the 21st Century Cures Act approaches its 4th anniversary, the National Comprehensive Cancer Network® (NCCN®) convened a working group made up of multidisciplinary experts from across the country to analyze current issues related to the 21st Century Cures Act and to develop recommendations for future policy improvements. The Co-Chairs of the working group—Jeff Allen,…
Executive Summary Duke-Margolis’ Mark McClellan touts the advantages networks have over individual operations, citing the dexamethasone RECOVERY trial, and notes need for real-world evidence infrastructure. In gathering data on potential COVID-19 therapeutics, clinical trial networks can accomplish what individual study sites are unable to do, Mark McClellan, director of the Duke-Margolis Center for Health Policy…
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. The Reagan-Udall Foundation for the FDA and…
Covid-19 vaccine tests should include racial and ethnic minorities, pregnant women, and patients with underlying health conditions, the FDA said, echoing calls from patient advocates to broaden the pool of participants. The Food and Drug Administration released guidance Tuesday that laid out the criteria for companies like Moderna Inc., Sanofi, and Johnson & Johnson…
Real-world data is everywhere. During the COVID-19 global pandemic, we are literally generating, and collecting, real-world data every single day—from electronic health records, insurance claims, patient registries, and a myriad of other sources. But the question remains: how do we use this data to better understand, prevent, and treat this disease? Data by itself…
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push…
The ongoing coronavirus disease 2019 (COVID-19) pandemic has magnified the value of real-world data (RWD) in oncology. The FDA is presently spearheading several initiatives aimed at refining the role of RWD in cancer care to guide clinical trial development, procure answers to pressing clinical questions, and support regulatory decisions for in vitro diagnostics, according to…
Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic reputation and an outsized personality to match. For years, rumors have swirled: Who could possibly succeed her? Now, it seems, there’s an answer to that question: The FDA official who has been tapped to step into Woodcock’s role for at least…
The US Food and Drug Administration (FDA) is collaborating with the Reagan-Udall Foundation and Friends of Cancer Research for a project called Covid-19 Diagnostics Evidence Accelerator. The project aims to enhance the development of coronavirus diagnostics. It will enable experts in health data to analyse diagnostic and clinical data in real-time and analyse what…
