The Evidence Hub: Perspectives in RWE

What I saw at ICPE 2023

Jade Cusick

Leveraging the SURF screening tool to understand how to identify whether RWE of effectiveness may be acceptable for regulatory decision-making for a clinical development program

Ulka Campbell, PhD

The Inflation Reduction Act Puts Real-World Evidence Front and Center

Carolyn Magill

Lowell Schiller, J.D.

Aetion submits comments to FDA on recent draft guidance on considerations for externally controlled trials

Nicolle Gatto, Ph.D., M.P.H.

Lowell Schiller, J.D.

Setting Real-World Standards at ISPOR 2023

Ashley Jaksa, MPH

Nirosha Lederer, PHD

Scientist spotlight: A deeper dive on RCT-DUPLICATE

Liz Garry, PhD, MPH

Liza Gibbs, MS

Research spotlight: RWD transferability across borders

Ashley Jaksa

Patrick Arena

A Solution for Payers to Use Real World Evidence in Pharma Confidently

The Aetion Value Based Solutions Team

RWE Meaning | Update: What the Omnibus FDA Amendments Mean for RWE

Lowell Schiller

Nicholaas Honig

RWE guidance watch: EUnetHTA’s Direct and Indirect Comparisons guidance

Ashley Jaksa, M.P.H.

Aetion’s best practices referenced in ENCePP’s updated Guide on Methodological Standards in Pharmacoepidemiology

Ulka Campbell, PhD

Why work at a startup? Because everything you do matters

John “Moose” Turek

ISPOR Goes Real-World

Ashley Jaksa, MPH

Nirosha Lederer, PhD

RWE Guidance: NICE’s RWE Framework

Ashley Jaksa

Aetion’s comments to FDA on data standards for RWD in drug and biological product submissions

Lowell Schiller, JD

Aetion’s comments to FDA on electronic health records and claims to support regulatory decisions

Lowell Schiller, JD

Understanding propensity score weighting methods

Why we acquired synthetic data pioneer Replica Analytics

Carolyn Magill

What I learned from former FDA leaders during Aetion’s RWE Summit

Carolyn Magill

Research spotlight: Using RWE to characterize prescription opioid dispensing patterns after surgical abortion

Liza Gibbs

What industry can learn from RWE demonstration projects

RWE guidance watch: EMA real world evidence guidance on registry-based studies

Ashley Jaksa, M.P.H.

Nick Honig

COVID-19 vaccine rollout shows real-world evidence was ready for the spotlight

Carolyn Magill

Join primary and real-world data to generate patient-relevant RWE across the product lifecycle: Q&A with Dr. Javier Jimenez of Syneos Health

ICPE Research Spotlight 2021: Part II: Forging methods to advance principled database epidemiology

ICPE Research Spotlight 2021: Part I: Findings from Aetion-FDA research collaboration to advance understanding of COVID-19 with RWE

RWE to inform value decision-making: Learnings from ICER’s 24-month reassessment pilot

Ashley Jaksa, MPH

Mandy Patrick, MS

Patient voice in RWE: Generating evidence that will impact payer and HTA decision-making

RWE Guidance Watch: IMPACT HTA publishes recommendations on the use of RWE in HTA

Ashley Jaksa, M.P.H.

An update on efforts to standardize and democratize RWE: Q&A with Dr. Nirosha Mahendraratnam Lederer

Research spotlight: Gilead Sciences and Aetion use RWE to assess the comparative effectiveness of remdesivir for COVID-19

Jennifer Hayden

Using RWE to characterize diseases as novel treatments become available: Q&A with Dr. Maria Schneeweiss

Research spotlight: Using RWD sources to describe the patient burden of a poorly understood rare disease

Liz Garry, Ph.D., M.P.H.

Research spotlight: Organized structure of RWE best practices

Ashley Jaksa, M.P.H.

Sarah Vititoe, M.P.H.

How NICE is approaching guidelines for RWE generation: Q&A with Dr. Páll Jónsson

Introducing the RWE Alliance: How a cross-industry coalition aims to advance RWE policy

How leading-edge teams are using RWE to accelerate drug development: A conversation with Janssen R&D and Sanofi

How payers and providers can leverage RWE: Q&A with Bill Guptail, SVP of Value-Based Care, Aetion

How using an RWE platform can support building regulatory-grade ECAs

Adina Estrin

RWE plays an integral role in NICE’s five-year strategy

Ashley Jaksa, M.P.H.

How RWE can support safety in Europe: Dr. Pierre Engel on leveraging innovative strategies to meet regulatory requirements

Research spotlight: Using RWE to assess molecular insights, published in Science

Jeremy Rassen, Sc.D.

Leveraging RWE in regulatory submissions of medical devices: Three takeaways for medical device and diagnostic companies

Christian Howell

Research spotlight: Using RWD to evaluate risk of COVID-19 reinfection

Carly Kabelac

Research spotlight: Understanding and correcting bias in RWE studies

Jeremy Rassen, Sc.D.

How RWE can support drug development during COVID-19 and beyond: Q&A with Dr. Diana Brainard of Gilead Sciences

How RWE can advance understanding of—and boost public confidence in—COVID-19 vaccine safety

Carolyn Magill

Opportunities to advance RWE in Europe: Assessing today’s landscape and priorities for future guidance

Ashley Jaksa, M.P.H.

Nicolas Deltour, M.Sc.

How medical device companies can use RWE to drive impact for patients: Q&A with Christian Howell, Aetion’s VP/GM of Medical Devices and Diagnostics

Sourcing global real-world data to support R&D: Q&A with Ian Rentsch, VP of Growth and Strategic Partnerships, Aetion

Real-world data in the era of COVID-19: Expert perspectives on the changing data landscape

Nicolle Gatto, Ph.D.

Applying regulatory experience in the technology space: Q&A with Lowell Schiller, Chief Legal and Regulatory Officer at Aetion

Research spotlight: Using RWE to evaluate complications of COVID-19

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

Interim results of the RCT-DUPLICATE Project: Dr. Jessica Franklin on learnings thus far

RWE Guidance Watch: NICE updates methods for health technology evaluations

Ashley Jaksa, M.P.H.

RWE Guidance Watch: MHRA draft guidance on RCTs generating RWE to support regulatory decisions

Nick Honig

Nirosha Mahendraratnam Lederer, Ph.D.

How can real-world data support opioid addiction research? Q&A with Dr. Jacob “Gus” Crothers of Groups Recover Together

ICPE research spotlight: Part III: Standard-setting research to advance the use of RWE

Generating real-world evidence from chargemaster data: Q&A with Myla Maloney of Premier, Inc.

How can small- to mid-sized biopharma generate insights from RWD? Q&A with Michael Sanky of Optum Life Sciences

Unlocking insights in RWD for market access and commercial teams: Q&A with Ki Park of Symphony Health

ICPE research spotlight: Part II: Exploring new methods for RWE research

Ask the Accelerators: Dr. William Morice of Mayo Clinic Laboratories on RWE and COVID-19 diagnostics

ICPE research spotlight: Part I: Expanding real-world applications of RWE

Ask the Accelerators: Dr. Nirosha Lederer on COVID-19’s implications for the future of RWE, and what we’ve learned so far

Three recommendations for generating regulatory-grade RWE: Considerations for the FDA on PDUFA VII

Jeremy Rassen, Sc.D.

Structuring epidemiology teams to maximize impact of RWE: Q&A with Dr. Nicolle Gatto

How can AI and RWD work together to improve understanding of chronic diseases? Q&A with Kathryn Starzyk, Head of RWE at OM1

Real-world evidence and regulatory decision-making: A round-up of readings on progress to date, and what’s to come

Olivia Rybolt

Lessons from four recent FDA decisions in infectious disease

Christina Purpura

Ray Harvey

The Cures Act’s second act: Six ways to ensure Congress doubles down on its boldest bet

Carolyn Magill

How to generate insights on COVID-19 interventions with real-world data: Three learnings from the COVID-19 Therapeutics Evidence Accelerator

Nicolle Gatto, Ph.D.

Liz DeMatteis

What’s ahead for the use of RWE by regulators and HTAs? Q&A with Dr. Lucinda Orsini, Associate Chief Science Officer of ISPOR

Financing innovative therapies in the era of COVID-19: The collaborative work ahead

Maya Tsukernik

The case for regulator-HTA collaboration on RWE methodology standards

Ashley Jaksa, M.P.H.

Trends and predictions for RWE: Perspectives from Dr. Sean Hennessy, pharmacist and pharmacoepidemiologist

Q&A with Dr. Nicolle Gatto: Leveraging external comparators for drug development and COVID-19 research

The causal revolution in observational research: Breaking the causality taboo

Jeremy Rassen, Sc.D.

How can biopharma use oncology real-world data to support clinical development? Q&A with Viraj Narayanan, VP of Life Sciences, COTA

COVID-19: The critical role of real-world evidence made real

Carolyn Magill

FDA vaccine approval and common self-controlled study designs for vaccine safety testing

Pattra Mattox, S.M., C.M.P.P.

Mandy Patrick, M.S.

HTAs and RWE: Current use, predicted trends, and next steps for biopharma

Ashley Jaksa, M.P.H.

Priorities for modernizing ClinicalTrials.gov: Five ideas to facilitate transparency in observational research

Ilker Oztop, Ph.D.

Real-world evidence and COVID-19: Empower rapid, reliable, data science-driven decisions

Liz DeMatteis

Abby Stockwell

The surge in RWE supported FDA approvals: A look at three FDA decisions

Christina Purpura

Optimizing pharma organizational design for effective use of real-world evidence

Maya Tsukernik

How RWE can inform cancer care: Q&A with Dr. Deb Schrag, oncologist and observational researcher

How can you leverage RWE to help advance your organization’s goals? Q&A with Dr. Yin Ho

How to plan for evidence generation in a time of uncertainty

Carolyn Magill

COVID-19: Recommended readings and resources from Aetion scientists

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

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

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

Liz DeMatteis

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

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

How emerging technologies will ensure increasing availability of RWD

Yin Ho, M.D., M.B.A.

Contextual considerations in RWE generation and use

Ashley Jaksa, M.P.H.

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

Ashley Jaksa, M.P.H.

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

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

Maya Tsukernik

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

Ashley Jaksa, M.P.H.

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

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

Brittany Ryan

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

Carolyn Magill

Learnings from three FDA decisions on ECA submissions in oncology

Ilker Oztop, Ph.D.

Spotlight on trust and transparency at ISPOR Europe 2019

Ashley Jaksa, M.P.H.

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

Julia Wu

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

Liz DeMatteis

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

Christina Purpura

The case for real-world evidence in health technology assessment

Ashley Jaksa, M.P.H.

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

Tolu Ajiboye

Everyone in the pool: How diverse stakeholders speed RWE adoption

Jocelyn Wang, M.S.

Takeaways from the 35th ICPE

Olivia Rybolt

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

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

Olivia Rybolt

The case for real-world evidence in Germany

Ashley Jaksa, M.P.H.

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

Christina Purpura

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

Kristen Deken, M.B.A.

Jeremy Rassen, Sc.D.

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

Liza Gibbs

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

Gale Pryor

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

Health Canada moves to adopt real-world evidence

Ashley Jaksa, M.P.H.

Four takeaways from ISPOR 2019

Ashley Jaksa, M.P.H.

Correlated or causal? Exchangeability and propensity score modeling explained

Amanda Kelly, M.S.

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

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

Future sources of real-world data: Opportunities and challenges

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

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

Christina Purpura

Real-world evidence use cases: A round up of essential sources of information

Olivia Rybolt

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

Gale Pryor

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

Gale Pryor

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

Jeremy Rassen, Sc.D.

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

Priscilla Velentgas, Ph.D.

The perils of immortal time bias

Sruthi Adimadhyam, Ph.D.

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

Jeremy Rassen, Sc.D.

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

Natalia Petruski-Ivleva, Ph.D.

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

Welcome to the Evidence Hub

Carolyn Magill

Four questions to ask your data

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

Framework for FDA’s Real-World Evidence Program: Dr. Sebastian Schneeweiss considers implications for biopharma

A year of acceleration: Looking ahead at 2019

Bill Geary

Leading change at Pfizer: A conversation with Chris Boone