Welcome to the Evidence Hub

Carolyn Magill
,
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.

Read more
View allMost RecentMost Read
Insights
NEW
September 12, 2019

What can electronic health records tell us—and how?
Q&A with Andrew Bate, Ph.D.

With biopharma and regulatory agencies continuing to experiment with the role of real-world evidence in regulatory decision-making, data quality and fitness for purpose rises to the top of important factors to consider. Here, Andrew Bate, Ph.D., Senior Director and Analytics Team Lead for Epidemiology at Pfizer, explores the opportunities and challenges of working with electronic health record data.

Read moreRead more
Insights
NEW
August 30, 2019
Olivia Rybolt

Know your database—and its culture:
Working with global real-world data sets

To understand a database, a researcher must understand the culture and policies of the setting in which it was created—especially when working with international or multinational data. The Japanese Medical Data Center (JMDC Inc.), part of the Aetion Data Network, is one such resource, and Olivia Rybolt breaks down the Japan-specific health care factors that make that data unique.

Read moreRead more
Insights
NEW
August 20, 2019
Ashley Jaksa, M.P.H.

The case for real-world evidence in Germany

German health technology assessment (HTA) agencies are exploring ways to improve their drug development and regulatory approval processes after a recent study in the British Medical Journal showed that most new drugs entering their market don’t have an added benefit over existing therapies. Aetion responded, and Ashley Jaksa elaborates here on the potential for real-world evidence to assess value of drugs for German HTAs.

Read moreRead more
Insights
NEW
July 26, 2019
Christina Purpura

Writing the perfect cover letter:
A look at the FDA’s forthcoming guidance on submitting RWE studies

In their continued effort to explore and evaluate the potential of real-world evidence in regulatory submissions, the FDA released a draft guidance for a uniform cover letter that would identify when submissions used RWE. Industry weighed in, providing recommendations that could shape FDA’s guidance, and Aetion’s Christina Purpura outlines key takeaways.

Read moreRead more
Insights
NEW
June 25, 2019
Kristen Deken, M.B.A.

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

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.

Read moreRead more
Features
Insights
NEW
June 21, 2019
Liza Gibbs

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

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.

Read moreRead more
Features
Event recaps
Insights
NEW
June 14, 2019
Gale Pryor

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

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.

Read moreRead more
Q&As
NEW
June 7, 2019

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

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.

Read moreRead more
Insights
Features
NEW
May 31, 2019
Ashley Jaksa, M.P.H.

Health Canada moves to adopt real-world evidence

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?

Read moreRead more
Event recaps
NEW
May 24, 2019
Ashley Jaksa, M.P.H.

Four takeaways from ISPOR 2019

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.

Read moreRead more
Methods
NEW
May 17, 2019
Amanda Kelly, M.S.

Correlated or causal?
Exchangeability and propensity score modeling explained

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.

Read moreRead more
Q&As
Insights
NEW

Methods, approaches, and predictions:
Dr. Jessica Franklin discusses RCT DUPLICATE

RCT DUPLICATE, a demonstration project in partnership with the FDA, Brigham and Women's Hospital, and Harvard Medical School, seeks to establish standards for real-world evidence trials. We ask the lead researcher, Jessica Franklin, Ph.D., about her protocol and study design to attempt to replicate 30 randomized controlled trials and predict seven ongoing RCTs using real-world data.

Read moreRead more
Q&As
NEW
May 3, 2019

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

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.

Read moreRead more
Insights
Features
NEW
April 26, 2019
William Murk, Ph.D., M.P.H.

Future sources of real-world data:
Opportunities and challenges

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.

Read moreRead more
Event recaps
NEW
April 19, 2019
Christina Purpura

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

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.

Read moreRead more
Resource roundups
NEW
April 12, 2019
Olivia Rybolt

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

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.

Read moreRead more
Insights
Features
NEW
April 5, 2019
Gale Pryor

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

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?

Read moreRead more
Insights
Features
NEW
March 21, 2019
Gale Pryor

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

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.

Read moreRead more
Methods
Insights
NEW
March 15, 2019
Jeremy Rassen, Sc.D.

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

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.

Read moreRead more
Methods
NEW
March 1, 2019
Sruthi Adimadhyam, Ph.D.

The perils of immortal time bias

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.

Read moreRead more
Q&As
NEW
January 31, 2019

Leading change at Pfizer:
A conversation with Chris Boone

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.

Read moreRead more
Methods
Insights
NEW
February 15, 2019
Natalia Petruski-Ivleva, Ph.D.

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

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.

Read moreRead more
Methods
Insights
NEW
February 22, 2019
Jeremy Rassen, Sc.D.

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

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.

Read moreRead more
Methods
Insights
NEW
March 8, 2019
Priscilla Velentgas, Ph.D.

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

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.

Read moreRead more
Q&As
Insights
NEW
January 31, 2019

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

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.

Read moreRead more
Insights
NEW
January 31, 2019
William Murk, Ph.D., M.P.H.

Four questions to ask your data

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

Read moreRead more
Insights
NEW
January 31, 2019
Bill Geary

A year of acceleration:
Looking ahead at 2019

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."

Read moreRead more
Q&As
NEW
February 8, 2019

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

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.

Read moreRead more

The Evidence Digest

Subscribe to our newsletter for insights and updates on real-world evidence research and applications.
Thank you, you've been subscribed.
Oops! Something went wrong while submitting the form.
©2018 Aetion, Inc.      Terms of Use      Privacy Policy      Patents