Blog
The case for real-world evidence in health technology assessment
New drugs are launched based on data from randomized controlled trials (RCTs), the gold ...
Presentation
An Introduction to Synthetic Clinical Trial Data
Blog
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 ...
Blog
Everyone in the pool: How diverse stakeholders speed RWE adoption
A recent issue of Clinical Pharmacology & Therapeutics focused entirely on real-world ...
Blog
Takeaways from the 35th ICPE
At the end of August, pharmacoepidemiology enthusiasts from across the globe gathered in ...
Blog
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 ...
Blog
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 ...
Blog
The case for real-world evidence in Germany
A recently published study in the British Medical Journal by Wieseler et al. of the ...
Blog
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In May 2019, the U.S. Food and Drug Administration (FDA) released a draft guidance that ...
Blog
Reflections on Generating Synthetic Data for the Vivli-Microsoft Data Challenge
This June, we generated synthetic clinical trial data for the inaugural Vivli-Microsoft ...
Blog
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 ...
Blog
Reproductive health and opioids: How real-world evidence reveals patients’ stories
Research conducted using real-world data (RWD) in recent years has increased our ...
Blog
Addressing the determinants of health: What is pharma’s role?
As recognition grows that health care is broader than medical care, innovative ...
Blog
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, ...
Blog
Health Canada moves to adopt real-world evidence
On April 16, 2019, Health Canada announced a new position to leverage real-world evidence ...
Blog
Four takeaways from ISPOR 2019
At the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) 24th ...
Blog
Correlated or causal? Exchangeability and propensity score modeling explained
When designing comparative studies, epidemiologists aim for exchangeability between ...
Blog
Methods, approaches, and predictions: Dr. Jessica Franklin discusses RCT DUPLICATE
Known as a “methods wiz” among her collaborators, Jessica Franklin, Ph.D., dedicates her ...
Article
Cutter Publishes Update on Synthetic Data
The Cutter Consortium just published an executive update on synthetic data that is ...
Blog
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 ...
Blog
Future sources of real-world data: Opportunities and challenges
Today, real world data (RWD) primarily consists of administrative claims databases, ...
Blog
Replica Analytics Generates Data for Vivli Innovation Challenge
On 21st June Vivli and Microsoft will be hosting an innovation challenge (datathons) on ...
Blog
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 ...
Blog
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 ...