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.

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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.

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NEW
May 10, 2019

Predicting randomized trials with RWD:
Jessica Franklin, Ph.D., explains why FDA has extended the RCT DUPLICATE project

In a recently announced extension, the RCT DUPLICATE Project will conduct seven additional studies that predict the results of ongoing trials. We ask Jessica Franklin, PhD., lead for the project, about the impetus for predicting, as well as emulating, randomized controlled trials with real-world data.

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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 clinical randomized 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
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.

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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.

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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.

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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?

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March 27, 2019

Setting standards with RCT DUPLICATE:
A conversation with Jessica Franklin, Ph.D.

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 about her protocol and study design to replicate 30 randomized controlled trials and predict seven ongoing RCTS using real-world data.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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."

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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.

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NEW
May 17, 2019

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
NEW
May 10, 2019

Predicting randomized trials with RWD:
Jessica Franklin, Ph.D., explains why FDA has extended the RCT DUPLICATE project

In a recently announced extension, the RCT DUPLICATE Project will conduct seven additional studies that predict the results of ongoing trials. We ask Jessica Franklin, PhD., lead for the project, about the impetus for predicting, as well as emulating, randomized controlled trials with real-world data.

Read moreRead more
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 clinical randomized 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
NEW
April 26, 2019

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

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