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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In May 2019, the U.S. Food and Drug Administration (FDA) released a draft guidance that ...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 ...
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Real-world evidence use cases: A round up of essential sources of information
For those looking to learn more about real-world evidence (RWE), there is a wealth of ...
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Real Data vs Synthetic Data: Propagating Constraints
As we are working through a number of data generation projects, one issue that has come ...
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A perfect data set? Yes and no: The All of Us Project
In an ideal world, all health data would be meticulously collected, capture the whole ...
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Real-world evidence shows that prescription amphetamine use increases risk of psychosis in ADHD
Five million people under the age of 25 in the U.S. are prescribed stimulants to treat ...
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Why does traceability data matter—and how do platforms help?
When considering the use of real-world evidence (RWE) for decision-making purposes, we ...
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The epidemiology of databases: Part III: The expanding uses of real-world evidence
Part I: Four principles of working with real-world data
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The perils of immortal time bias
In the early 2000s, a study published in the Annals of Internal Medicine reported that ...
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The epidemiology of databases: Part II: Four principles of generating real-world evidence
In a recent comment letter to the U.S. Food and Drug Administration, Aetion outlined key ...