Coverage

Accelerating the fight against COVID-19 with real-world data on tests - BioCentury
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…
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To expedite progress against COVID-19, a public-private “accelerator” taps into real-world data - The Cancer Letter
This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
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Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency'
The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a…
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FDA joins new, public-private COVID-19 diagnostic research accelerator effort - FierceBiotech
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…
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New accelerator to boost real-world COVID-19 diagnostics - Regulatory Focus
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…
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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 this 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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