The Evidence Hub

What we're thinking

Tap into perspectives and best practices in real-world evidence from scientific and industry leaders engaged in treatment development, commercialization, and payment innovation.

Insight
February 1, 2019

Welcome to the Evidence Hub

Carolyn Magill
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CEO, Aetion

Welcome to the Evidence Hub, an ongoing conversation about perspectives, milestones, and best practices in applying real-world evidence in life sciences and value-based health care. Here is where we share our thinking—and invite your thinking—about one of the most powerful levers we have to fix health care: data.

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June 25, 2019

Predicting the CAROLINA trial with real-world evidence:
Three takeaways for pharma

Kristen Deken, M.B.A.
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director, Labs Operations, Aetion

RCT DUPLICATE’s pilot study used real-world evidence to predict results of CAROLINA, a randomized controlled trial. The results build optimism for the role of RWE in regulatory decision-making. How should biopharma prepare for this paradigm shift? Kristen Deken, M.B.A., and Jeremy Rassen, Sc.D., outline three next steps for industry.

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June 21, 2019

Reproductive health and opioids:
How real-world evidence reveals patients’ stories

Liza Gibbs
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Senior scientific analyst, Aetion

Opioid-related deaths are rising more sharply in women than in men, and real-world data analyses have shone light on three potential contributing factors to the epidemic. Aetion scientist Liza Gibbs reviews recent studies—and how RWD can increase understanding of women’s clinical experiences.

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June 14, 2019

Addressing the determinants of health:
What is pharma’s role?

Gale Pryor
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Editor, The Evidence Hub

Addressing the social determinants of health to improve outcomes is an all-hands-on-deck endeavor across the health care ecosystem. What is pharma’s role? Christopher Boone of Pfizer explains.

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June 7, 2019

How real-world evidence supports outcomes-based care and contracting:
A conversation with Saira Jan, M.S., Pharm.D.

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As they venture into a value-based landscape, payers are turning to real-world evidence analyses to improve members’ health and support outcomes-based contracting with pharma. Saira Jan, M.S., Pharm.D., of Horizon Blue Cross Blue Shield of New Jersey, explains how Horizon is identifying risks and designing interventions with real-world data analyses.

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May 31, 2019

Health Canada moves to adopt real-world evidence

Ashley Jaksa, M.P.H.
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Contributor, Aetion

As Canadian regulators move to adopt real-world evidence in decision-making to improve access to treatments in Canada, will they view evidence as hierarchical or fit for purpose?

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May 24, 2019

Four takeaways from ISPOR 2019

Ashley Jaksa, M.P.H.
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Contributor, Aetion

At the ISPOR's 24th Annual International Meeting in New Orleans, researchers and speakers highlighted emerging trends in data-driven decision-making. Here, Ashley Jaksa, M.P.H., outlines four key takeaways from the conference.

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May 17, 2019

Correlated or causal?
Exchangeability and propensity score modeling explained

Amanda Kelly, M.S.
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Scientist, Aetion

In the real world, treatment decisions depend on patients’ age, gender, medical history, lifestyle, and more. These variable factors can also be confounders in assessing the success of a treatment. Here’s how propensity score modeling addresses them.

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May 3, 2019

Do real-world evidence studies require a separate registry?
A conversation with Richard Willke, Ph.D.

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Researchers are submitting real-world evidence trials to ClinicalTrials.gov and other registries designed for randomized controlled trials. We ask Richard J. Willke, Ph.D., chief science officer for ISPOR, why a separate registry for real-world data studies may—or may not—be needed.

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April 26, 2019

Future sources of real-world data:
Opportunities and challenges

William Murk, Ph.D., M.P.H.
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Epidemiologist

From Fitbits to voice assistants, the digitization of daily life means health care data collection is rapidly moving beyond claims and EHR data. Epidemiologist William Murk takes a look at how novel data sources may inform research studies in the not-so-distant future.

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April 19, 2019

A shared learning process:         
3 takeaways from the Harvard-MIT Center for Regulatory Science’s annual meeting

Christina Purpura
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Contributor, The Evidence Hub

On April 2, 2019, FDA staff and industry leaders met at the Harvard-MIT CRS Regulatory Science Symposium to discuss challenges and advances in the field. Policy expert Christina Purpura sums up key learnings from the conference. First, adopting real-world evidence is a shared learning process among all stakeholders.

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April 12, 2019

Readings in real-world evidence:
A round up of essential sources of information

Olivia Rybolt
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Contributor, the Evidence Hub

Real-world evidence is a hot topic in drug development, yet many are still getting up to speed on the concepts and impact of RWE. Here, we've rounded up a foundation of helpful resources for stakeholders in pharma and beyond.

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April 5, 2019

A perfect data set?          
Yes and no: 
The All of Us Project

Gale Pryor
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Editor, The Evidence Hub

The National Institute of Health's All of Us Research Program aims to produce comprehensive, longitudinal health data from one million Americans, a scope of health data previously unseen and a big step toward precision medicine. But what are its potential limitations?

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Feature
March 21, 2019

Real-world evidence shows that prescription amphetamine use increases risk of psychosis in ADHD

Gale Pryor
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Editor, The Evidence Hub

While it has long been known that stimulants prescribed for ADHD have a low risk of psychosis, the difference in risk between those most commonly prescribed has not. In a real-world evidence study published in The New England Journal of Medicine, McLean Hospital researcher Lauren Moran, M.D., determines that amphetamines carry a higher risk for people under the age of 25 than other stimulants. We speak with her about her methods and findings.

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Insight
March 15, 2019

Why does data traceability matter—and how do platforms help?

Jeremy Rassen, Sc.D.
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Co-Founder, President, and Chief Science Officer, Aetion

Data traceability underpins the transparency, reproducibility, and the validity of real-world evidence studies. Jeremy Rassen, Sc.D., explains why—and how platforms can ensure traceability.

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March 1, 2019

The perils of immortal time bias

Sruthi Adimadhyam, Ph.D.
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Senior Scientist, Aetion

Aetion senior scientist Sruthi Adimadhyam, Ph.D., explains the implications of immortal time bias in real-world data studies, and what real-world data scientists can do to eliminate it.

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Q&A
January 31, 2019

Leading change at Pfizer:
A conversation with Chris Boone

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As Pfizer embraces a digital transformation—reimagining business and operating models to embrace the role of all data in decision making and strategy—Chris Boone leads the way as lead for Pfizer's Real-World Data and Analytics Center of Excellence. Recently, he spoke with the Evidence Hub about his mission to ensure that real-world evidence delivers value in the search for innovative medicines.

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Insight
February 15, 2019

The epidemiology of databases
Part I: Four principles of working with real-world data

Natalia Petruski-Ivleva, Ph.D.
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Senior Scientist, Aetion

As FDA launches its formal exploration of the use of real-world evidence in regulatory decision-making, Aetion has joined the industry-wide shared learning process. In a three-part series, we outline our key principles of database epidemiology. Natalia Petruski-Ivleva, Ph.D., addresses four principles of working with real-world data.

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Insight
February 22, 2019

The epidemiology of databases
Part II: Four principles of generating real-world evidence

Jeremy Rassen, Sc.D.
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Co-Founder, President, and Chief Science Officer, Aetion

As FDA launches its formal exploration of the use of real-world evidence in regulatory decision-making, Aetion has joined the industry-wide shared learning process. Jeremy Rassen, Sc.D., presents four principles of generating real-world evidence.

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Insight
March 8, 2019

The epidemiology of databases
Part III: The expanding uses of real-world evidence

Priscilla Velentgas, Ph.D.
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Senior Director of Science, Aetion

As FDA launches its formal exploration of the use of real-world evidence in regulatory decision-making, Aetion has joined the industry-wide shared learning process. Priscilla Velentgas, Ph.D., outlines current and future applications of real-world evidence.

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Q&A
January 31, 2019

Framework for FDA's Real-World Evidence Program:
Sebastian Schneeweiss considers implications for biopharma

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In December 2018, FDA unveiled its real-world data strategy for regulatory decision-making in Framework for FDA’s Real-World Evidence Program, marking a new phase in accelerating medical product development and innovation. We spoke with Sebastian Schneeweiss, Sc.D., M.D., to learn the implications of the Framework for biopharma and payers.

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January 31, 2019

Four questions to ask your data

William Murk, Ph.D., M.P.H.
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Epidemiologist

Epidemiologist William Murk, Ph.D., M.P.H., outlines four key considerations for evaluating data quality before designing real-world evidence studies.

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Insight
January 31, 2019

A year of acceleration:
Looking ahead at 2019

Bill Geary
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Co-Founder and Partner, Flare Capital Partners

Bill Geary, a co-founder and partner at Flare Capital Partners, a leading health care technology venture capital firm, looks forward at 2019 and predicts a watershed year for health care transformation. From chronic care to real-world data, he says, "those who lead will be rewarded."

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Q&A
February 8, 2019

Where public health and quantitative science overlap:
A conversation with senior scientist Erin Comerford

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Where do public health and quantitative science overlap? When Erin Comerford, senior scientist at Aetion, went looking for a discipline in which she could pursue her twin fascinations, she found real-world evidence. We spoke with Erin about how RWE delivers clarity to the complex topic of aging and chronic illness.

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