The Evidence Hub

What we're reading

As real-world data becomes a validated tool driving the shift to outcomes-based health care, we’re all teachers and learners on this journey. We’ve asked our experts and partners to recommend their sources of essential information about real-world evidence from foundational to leading-edge required reading. Start and extend your own discovery process here.

December 12, 2018

FDA issues Real-World Evidence Framework for drugs and biologics

National Law Review

FDA’s Framework for Real-World Evidence Program provides guidelines for the agency’s use of RWE in drug approvals to date, and in the future. In this article, the National Law Review walks through the significance of the announcement and shines light on why FDA Commissioner Scott Gottlieb calls RWE a “top strategic priority.”

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December 6, 2018

Framework for FDA’s Real-World Evidence Program

U.S. Food and Drug Administration

The Framework for FDA’s Real-World Evidence Program presents the agency’s three-year strategy to evaluate how real-world data can be used in regulatory decision-making. The document marks a new phase in fulfilling the requirements of the 21st Century Cures Act to accelerate medical product development and innovation, giving patients faster access to new treatments.

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July 1, 2018

Real-world evidence: 
Driving a new drug-development paradigm in oncology

McKinsey & Company

Cancer is soon to become the leading cause of death in the United States, and despite the development of innovative therapies, costs and other impediments slow the progress of scientific breakthroughs. Here, McKinsey offers case studies and examples of how real-world evidence is likely to lead to improved treatment for people with cancer.

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June 28, 2018

Mission critical: 
Biopharma companies are accelerating real-world evidence adoption, investment, and application

Deloitte

Deloitte’s Second Annual RWE Benchmarking Survey shows a continued and increased adoption of real-world evidence by global life sciences companies. 90% of respondents report investing in RWE, and using it to support the development of value-based contracting agreements, regulatory submissions, and improved trial design.

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May 15, 2018

The Book of Why: The New Science of Cause and Effect

Judea Pearl and Dana Mackenzie

As an axiom, "correlation is not causation" has evolved into a decades-long taboo in science and academia of nearly any talk of causation. In "The Book of Why: The New Science of Cause and Effect," authors Judea Pearl and Dana Mackenzie usher in a new era for science in which advanced modeling tools enable data analyses that answer causal questions.

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May 1, 2018

Real-world evidence: 
From activity to impact in healthcare decision making

McKinsey & Company

As health care continues to focus on outcomes and value, real-world evidence can facilitate better decision-making by providers, biopharma, and payers. In this piece, McKinsey explores the benefits, risks, challenges, and potential applications of RWE to fit this role, concluding with a goal to create organizational cultures in which RWE drives innovation in health care.

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August 24, 2017

When and how can real-world data analyses substitute for randomized controlled trials

Jessica M. Franklin, Ph.D., and Sebastian Schneeweiss, M.D., Sc.D.

Real-world evidence is known as a faster and cheaper alternative to randomized controlled trials, but many remain unsure of the validity of RWE-driven insights for regulatory decision-making. This study, co-authored by Jessica Franklin, Ph.D., and Sebastian Schneeweiss, M.D., Sc.D., explores when and how to use real-world data for regulatory-grade analyses.

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