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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covid-19
coronavirus
real-world evidence
NEW
March 27, 2020
Carolyn Magill

How to plan for evidence generation in a time of uncertainty

As we all come to terms with the impact of Covid-19, the health care industry maintains focus on a common goal—ensuring patients receive safe and effective treatments with minimal delay. Here, Aetion's CEO Carolyn Magill discusses how RWE can support biopharma, physicians, and payers in this work as they ask critical questions regarding treatment and coverage.

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covid-19
coronavirus
pandemic
NEW
March 20, 2020

Covid-19: Recommended readings and resources from Aetion scientists

Amidst the global Covid-19 pandemic, we believe that a commitment to science is especially important to help us reach solutions. Here, Aetion's team of epidemiologists and science-minded colleagues share the readings that have helped them stay informed.

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real-world evidence
pfizer
science
NEW
March 12, 2020

Making the business case for RWE:
Julie Schiffman’s advice for biopharma on leveraging data to drive impact

Julie Schiffman recently joined Aetion as the Senior Vice President of Scientific Engagement, following 17 years in leadership roles at Pfizer. Here, Julie draws upon her experience working with biopharma to share insight on how to maximize the impact of RWE through a laser focus on business strategy.

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real-world evidence
data
patient
NEW
March 5, 2020

Psychiatrist and health care CEO Dr. Gary Gottlieb:
Treating the patient as a whole person

Throughout Dr. Gary Gottlieb’s career, he has led a hospital system and a global NGO, served patients as a psychiatrist, and taught the next generation of doctors at Harvard Medical School—all of which granting him a strong understanding of “whole patient care.” Read his perspective on how RWD can paint a fuller picture of patients’ needs to inform care decisions and enable innovative payment models.

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regulatory
standards
decision-making
NEW
February 27, 2020
Liz DeMatteis

Aetion, Dr. Scott Gottlieb, biopharma leaders’ discussions at JPM 2020:
It’s time to “knock on an open door” to further RWE standards and acceptance

At the 36th Annual J.P. Morgan Healthcare Conference, Aetion and Dr. Scott Gottlieb convened biopharma leaders to discuss RWE and the opportunities associated with increased adoption. The main takeaway? That biopharma’s demonstrated efforts to advance RWE signals an industry ready to move toward incorporating it in their regulatory strategy. Read on for perspectives on single-arm trials, regulator receptivity, and more, from Aetion’s Chief Marketing Officer, Liz DeMatteis.

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Methods
science
REPEAT
NEW
February 20, 2020

How to amplify RWE clarity and reproducibility with data visualizations:
Q&A with Dr. Shirley Wang of the REPEAT initiative

Real-world evidence generated from large health care database analyses can provide decision-makers with valuable insights, but inconsistencies and convoluted prose in study reports can slow their evaluation. Here, Shirley Wang, Ph.D., M.Sc., of Brigham and Women's Hospital, Harvard Medical School, and the REPEAT initiative, discusses a standardized visual reporting template that can ensure transparent and reproducible RWE.

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Q&As
technology
data
NEW
February 11, 2020

Why diverse data teams lead to bigger wins, and other perspectives from retail tech:
A Q&A with Stitch Fix CTO, Cathy Polinsky

Cathy Polinsky, Chief Technology Officer of Stitch Fix, has led technology teams at some of Silicon Valley's top organizations throughout her career. Now, as she joins Aetion's Board of Directors, she reflects on a common goal between the e-commerce world of Stitch Fix and the real-world evidence space: using data to inform better decisions.

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telemedicine
wearable
summit
NEW
February 6, 2020
Yin Ho, M.D., M.B.A.

How emerging technologies will ensure increasing availability of real-world data

With the development of new technologies in health care—such as telemedicine and wearables—so too come opportunities for researchers and clinicians to expand the scope of clinical care and research through increased access to RWD. Here, Yin Ho, M.D., M.B.A., summarizes a discussion from the inaugural Aetion Summit on the potential impact of these technologies, featuring insights from health care futurists from academia and biopharma.

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Insights
NEW
January 30, 2020
Ashley Jaksa, M.P.H.

Contextual considerations in RWE generation and use

As RWE continues to gain traction, questions remain about how to best use it—and when RWD is the right evidence base to answer a research question. Here, we break down some of the major considerations researchers must evaluate when planning an analysis, and why context matters in deciding whether or not RWE will be of use.

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Insights
NEW
January 23, 2020
Ashley Jaksa, M.P.H.

The shift from health technology assessment to management:
What is RWE’s role?

To enable them to better evaluate how drugs perform in clinical practice over time, HTA agencies are shifting their evaluation strategy from one of assessment to management, meaning they’ll regularly evaluate how products work in populations and adjust its value accordingly rather than make an evergreen value decision when the drug enters the market. Real-world evidence can help HTAs in this shift, and Ashley Jaksa, M.P.H., explores how, providing guidance for biopharma on how to prepare.

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Features
Event recaps
Insights
NEW
January 9, 2020
Maya Tsukernik

RWE and the value equation:
U.S. health care purchaser perspectives on payment model evolution and the role of RWE

As stakeholders evaluate important questions in health care payments models, real-world evidence has emerged as a useful tool to gather insights that can improve decision-making. Here, Maya Tsukernik, Vice President of New Product Development at Aetion, discusses ways employers, the public sector, and consumers can leverage RWE, based on a discussion with U.S. payers from the inaugural Aetion Summit.

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HTA
health technology assessment
ISPOR
NEW
January 15, 2020

RWE use by HTAs: How has it evolved, and where is it headed next?
Q&A with Dr. Jens Grueger

The increasing adoption of real-world evidence by health technology assessment agencies in decision-making opens the door for collaboration between biopharma and HTAs in value discussions. Here, Jens Grueger, Ph.D., affiliate professor at the University of Washington, former head of global access at Roche, and president-elect of the Professional Society for Health Economics and Outcomes Research (ISPOR), weighs in on the future of RWE and HTAs.

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health technology assessment
HTA
decision-making
NEW
December 19, 2019
Ashley Jaksa, M.P.H.

Let’s talk about value:
How biopharma can maximize utility of RWE in value discussions

In Aetion’s recent webinar with eyeforpharma on using real-world evidence to help biopharma and HTAs determine drug value, over one-third of the audience agreed that RWE is now a necessary aspect of their work. Here, Ashley Jaksa, M.P.H., breaks down key opportunities for biopharma highlighted in the webinar.

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real-world evidence
CPT
NEW
September 26, 2019
Jocelyn Wang, M.S.

Everyone in the pool:
How diverse stakeholders speed RWE adoption

In a recent issue of Clinical Pharmacology & Therapeutics, a wide range of stakeholders contributed to creating an entirely real-world data and real-world evidence-focused journal. Aetion scientist Jocelyn Wang, M.S., breaks down the key themes in the issue, how they relate to her work, and why contribution from a range of stakeholders is important in the effort to advance RWE adoption.

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Event recaps
Insights
NEW
November 14, 2019
Ashley Jaksa, M.P.H.

Spotlight on trust and transparency at ISPOR Europe 2019

At ISPOR Europe 2019, transparency and trust in real-world evidence stood out as a prominent theme, which is in line with broader initiatives by the ISPOR-ISPE Joint Task Force. Ashley Jaska, M.P.H., Vice President of Analytical Solutions at Aetion, breaks down the conversations around transparency, reproducibility, and standardization in methods that took place over five days of short courses and sessions in Copenhagen.

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summit
oncology
standards
NEW
December 6, 2019
Brittany Ryan

Advancing cancer care with real-world data: Next steps for collaborators

With the majority of treatment experiences in cancer care occurring outside of clinical trials, there is a tremendous opportunity for real-world data in oncology. But how can stakeholders work past roadblocks like interoperability to unlock its potential? Brittany Ryan, Senior Director of Product Strategy and Insights at Aetion, shares next steps as articulated by leaders from Friends of Cancer Research, Dana-Farber Cancer Institute, and the Institute for Clinical and Economic Review (ICER) at Aetion's inaugural customer summit.

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Insights
Q&As
Methods
NEW
December 13, 2019

Ask our experts:
Working with real-world data: What types of questions can your data answer?

The promise of real-world evidence comes with a steep learning curve, but Aetion's experts can help answer common questions about working with real-world data. In this Q&A, Emily Rubinstein, M.P.H., Senior Director of Global Data, responds to queries about assessing real-world data sets, and how regulators may assess an RWD submission.

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oncology
cancer
data
NEW
October 30, 2019
Liz DeMatteis

RWE advances amidst “data tsunami”:
Takeaways from FOCR 8th Annual Blueprint for Breakthrough Forum

“It’s not enough to ask what we are going to do about RWE today, but also, where should we be in ten years?" asked acting FDA Commissioner Ned Sharpless, M.D., at the Friends of Cancer Research 8th Annual Blueprint for Breakthrough Forum. The Aetion team was present for that daylong discussion, during which attendees explored the potential uses—and challenges of using—RWE in regulatory and payer decision-making in oncology. Liz DeMatteis, Chief Marketing Officer, expands on what she heard onsite.

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hlth
FDA
technology
NEW
November 7, 2019
Julia Wu

Bold moves in RWE — from FDA, industry, and tech at HLTH 2019

At this year's HLTH conference, which explored a range of health care issues and ideas, real-world evidence stood out as a hot topic. Julia Wu expands on regulatory, biopharma, and technology insights shared during the event, and how each stakeholder group is making strides to advance RWE.

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summit
FDA
decision-making
NEW
November 22, 2019
Carolyn Magill

Evidence at the Apex:
Five learnings from the first annual Aetion Summit

The inaugural Aetion Summit in October brought together some of the best minds in health care to discuss RWE and its transformative role in the development, delivery, and payment of treatments. Carolyn Magill, CEO of Aetion, distills her insights from the event, including embracing causality, RWE in patient care, HTAs’ use of RWE for value assessment, and Dr. Scott Gottlieb's, former commissioner of the FDA and Aetion board member, thoughts on RWE’s acceptance by regulators.

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pfizer
decision-making
data
NEW
September 12, 2019

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

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.

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regulatory
FDA
decision-making
NEW
October 24, 2019
Christina Purpura

FDA’s Technology Modernization Action Plan:
Three ways to prepare for the coming RWE infrastructure

On September 18, 2019, FDA's Office of Information Management and Technology (OIMT) released a Technology Modernization Action Plan. The project's goal is to build a formalized process for real-world evidence submissions and reviews, and is aligned with future technology updates in store for the agency. Contributing writer Christina Purpura breaks down what biopharma can expect from this plan, and how to prepare for when it goes into effect.

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Insights
NEW
December 12, 2019
Ashley Jaksa, M.P.H.

White paper: Real-world evidence and health technology assessment decision-making: What agencies—and their biopharma stakeholders—need to know

How will a drug that worked in a clinical trial work in clinical practice? Jens Grueger, Ph.D., and Ashley Jaksa, M.P.H., explain how real-world evidence can help bridge the "efficacy-effectiveness gap" in health technology assessment decision-making, including how biopharma can prepare for HTAs' shift toward RWE.

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Insights
NEW
November 21, 2019
Ilker Oztop, Ph.D.

Learnings from three FDA decisions on external control arm submissions in oncology

As industry prepares for FDA to release a full guidance around real-world evidence, they’ve been tasked with submitting RWE for regulatory approvals to determine when and how RWE can be used for regulatory decisions. Aetion is compiling a full library of these RWE submission examples, but in the meantime, Ilker Oztop, Ph.D., Analytic Solutions Manager at Aetion, shares three instances in which FDA did not deem the RWE regulatory-grade in external control arm submissions, and steps biopharma can take to avoid similar outcomes.

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jmdc
japan
data
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.

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Insights
NEW
October 11, 2019
Ashley Jaksa, M.P.H.

The case for real-world evidence in health technology assessment

Though randomized controlled trial data can provide insight into the efficacy of a drug, it's unable to determine its effectiveness in the real world — a conundrum known as the efficacy-effectiveness gap. Real-world evidence (RWE) can provide that effectiveness data that health technology assessment (HTA) agencies need in their decision-making. Read on as Ashley Jaksa explains RWE's clinical and economic use cases for HTAs.

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germany
HTA
health technology assessment
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.

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data
standards
technology
NEW
October 3, 2019
Tolu Ajiboye

On FHIR: How “Fast Healthcare Interoperability Resources” will improve real-world data quality

Electronic health records (EHRs) contain a wealth of patient health information, but a lack of interoperability between EHRs hinders their ability to be used by providers and in research. Fast Healthcare Interoperability Resources (FHIR), a data exchange standard that facilitates the transfer of health care information in real time, works to fix this problem, supporting the use of EHR data in real-world data analyses and more. Tolu Ajiboye, contributing writer for the Evidence Hub, explains here.

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FDA
decision-making
regulatory
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.

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ICPE
ISPE
decision-making
NEW
September 20, 2019
Olivia Rybolt

Takeaways from the 35th ICPE

The Aetion team was well represented this year at the 35th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), with over 20 presentations attributed to our scientists. The team gathered their learnings from ICPE into 5 key points for industry as biopharma, regulators, and other stakeholders continue to explore how real-world evidence can be used in regulatory decision-making.

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FDA
decision-making
RCT DUPLICATE
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.

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opioid
women's health
patient
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.

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Q&As
Insights
NEW
May 10, 2019

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.

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pfizer
patient
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.

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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.

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HTA
health technology assessment
canada
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?

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ISPOR
FDA
transparency
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.

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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.

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ISPOR
data
standards
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.

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data
technology
wearable
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.

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FDA
decision-making
regulatory
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.

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real-world evidence
learn
regulatory
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.

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data
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?

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ADHD
results
real-world evidence
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.

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Methods
transparency
fit for purpose
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.

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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.

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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.

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FDA
decision-making
regulatory
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.

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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.

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data
decision-making
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.

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decision-making
FDA
regulatory
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.

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pfizer
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.

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trends
real-world evidence
technology
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."

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Q&As
science
Methods
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.

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