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Evidence Hub

Blog
Aug 30, 2019

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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Blog
Aug 20, 2019

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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Blog
Jul 26, 2019

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In May 2019, the U.S. Food and Drug Administration (FDA) released a draft guidance that ...
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Blog
Jul 1, 2019

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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Blog
Jun 25, 2019

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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Blog
Jun 21, 2019

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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Blog
Jun 14, 2019

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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Blog
Jun 7, 2019

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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Blog
May 31, 2019

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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Blog
May 24, 2019

Four takeaways from ISPOR 2019

At the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) 24th ...
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Blog
May 17, 2019

Correlated or causal? Exchangeability and propensity score modeling explained

When designing comparative studies, epidemiologists aim for exchangeability between ...
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Blog
May 10, 2019

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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Blog
May 3, 2019

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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Blog
Apr 26, 2019

Future sources of real-world data: Opportunities and challenges

Today, real world data (RWD) primarily consists of administrative claims databases, ...
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Blog
Apr 24, 2019

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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Blog
Apr 20, 2019

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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Blog
Apr 12, 2019

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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Blog
Apr 12, 2019

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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Blog
Apr 5, 2019

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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Blog
Mar 21, 2019

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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Blog
Mar 15, 2019

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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Blog
Mar 8, 2019

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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Blog
Mar 2, 2019

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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Blog
Feb 23, 2019

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 ...
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