Coverage

US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines - Pinksheet
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…
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The pivotal role of real-world data in a pandemic - Biocentury
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…
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A New Trend in Drug Development: Leveraging Data from Expanded Access - Cancer Therapy Advisor
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…
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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 a blog post, talking about the benefits of considering clinical trials, in efforts to shift the…
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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…
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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…
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FDA Teams Up With Data Company Aetion to Study Virus Progression - Bloomberg Law
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.
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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…
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A New, Better Normal in Health Care? - National Review
The COVID-19 crisis has fast-tracked long-contemplated, patient-centric changes in medicine.
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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…
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