Blog
Bold moves in RWE — from FDA, industry, and tech at HLTH 2019
Two weeks ago, researchers at NYU published new findings on how objects move against a ...
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RWE advances amidst “data tsunami”: Takeaways from FOCR 8th Annual Blueprint for Breakthrough Forum
Breakthroughs in data extraction and analysis coupled with federal infrastructure ...
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FDA’s Technology Modernization Action Plan: Three ways to prepare for the coming RWE infrastructure
The U.S. Food and Drug Administration (FDA) recognizes that common standards and a shared ...
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The case for real-world evidence in health technology assessment
New drugs are launched based on data from randomized controlled trials (RCTs), the gold ...
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On FHIR: How “Fast Healthcare Interoperability Resources” will improve real-world data quality
In 2009, health care data entered the digital age with the HITECH Act and the ...
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Everyone in the pool: How diverse stakeholders speed RWE adoption
A recent issue of Clinical Pharmacology & Therapeutics focused entirely on real-world ...
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Takeaways from the 35th ICPE
At the end of August, pharmacoepidemiology enthusiasts from across the globe gathered in ...
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What can electronic health records tell us—and how? Q&A with Andrew Bate, Ph.D.
As pharma manufacturers and regulatory agencies increase the role of real-world data ...
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Know your database—and its culture: Working with global real-world databases
Health care databases are not created in a vacuum. They represent patients—people—and ...
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The case for real-world evidence in Germany
A recently published study in the British Medical Journal by Wieseler et al. of the ...
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Writing the perfect cover letter: A look at the FDA’s forthcoming guidance on submitting RWE studies
In May 2019, the U.S. Food and Drug Administration (FDA) released a draft guidance that ...
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Reflections on Generating Synthetic Data for the Vivli-Microsoft Data Challenge
This June, we generated synthetic clinical trial data for the inaugural Vivli-Microsoft ...
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Predicting the CAROLINA trial with real-world evidence: Three takeaways for pharma
The U.S. Food and Drug Administration has long relied on randomized controlled trials ...
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Reproductive health and opioids: How real-world evidence reveals patients’ stories
Research conducted using real-world data (RWD) in recent years has increased our ...
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Addressing the determinants of health: What is pharma’s role?
As recognition grows that health care is broader than medical care, innovative ...
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How real-world evidence supports outcomes-based care and contracting: A conversation with Saira Jan, Pharm.D., Horizon BCBSNJ
As the applications of real-world evidence (RWE) in pharmaceutical manufacturing expand, ...
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Health Canada moves to adopt real-world evidence
On April 16, 2019, Health Canada announced a new position to leverage real-world evidence ...
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Four takeaways from ISPOR 2019
At the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) 24th ...
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Correlated or causal? Exchangeability and propensity score modeling explained
When designing comparative studies, epidemiologists aim for exchangeability between ...
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Methods, approaches, and predictions: Dr. Jessica Franklin discusses RCT DUPLICATE
Known as a “methods wiz” among her collaborators, Jessica Franklin, Ph.D., dedicates her ...
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Do real-world evidence studies require a separate registry? A conversation with Richard Willke, Ph.D., Chief Science Officer, ISPOR
As FDA intensifies its focus on real-world evidence (RWE) and the work to establish ...
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Future sources of real-world data: Opportunities and challenges
Today, real world data (RWD) primarily consists of administrative claims databases, ...
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Replica Analytics Generates Data for Vivli Innovation Challenge
On 21st June Vivli and Microsoft will be hosting an innovation challenge (datathons) on ...
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A shared learning process: 3 takeaways from the Harvard-MIT Center for Regulatory Science’s annual meeting
Academe, U.S. Food and Drug Administration (FDA) staff, and industry leaders gathered at ...