ISPOR Real-World Evidence Summit 2023: what to expect

Written by The Evidence Base
Events coverage Health technology assessment ISPOR Real-world evidence Regulation

Taking place prior to the ISPOR 2023 conference, this one-day event will provide a comprehensive overview of the role of real-world evidence in regulatory decision-making and health technology assessment, and offer attendees the chance to learn from experts in the field.

View details of the ISPOR Real-World Evidence Summit 2023 >>

ISPOR has announced details of the ISPOR Real-World Evidence Summit 2023, happening on Sunday 7th May 2023 in Boston, USA. Co-located at ISPOR 2023, the summit is a collaboration between ISPOR, the International Society for Pharmacoepidemiology (ISPE), and the Duke-Margolis Center for Health Policy. The theme of the meeting is “Making Real-World Decisions with Real-World Evidence: From Frameworks to Practice.”

The program for the Summit is split into four sessions that include a wide range of experts in the field who will guide attendees through the opportunities and challenges in using real-world evidence (RWE) in regulatory decisions and health technology assessment (HTA).

Session 1: From Data Quality to Qualities

Moderated by Rachele Hendricks-Sturrup (Duke-Margolis Center for Health Policy, Washington, DC, USA), the first session will provide attendees with an in-depth look at data quality and how it is measured and assessed. By exploring recent frameworks and developments in validation, panellists Andre Araujo (GSK, Philadelphia, USA), Marni Hall (IQVIA, Rockville, USA) and Sebastian Schneeweiss (Harvard Medical School, Boston, USA) will ensure attendees gain a better understanding of how to ensure the data they are using is accurate, reliable, and fit-for-purpose.

Session 2: Considering Data Qualities in Determining Fit-for-Purpose – Can We Converge on an Approach?

Marc Berger (Marc L. Berger, LLC, USA) is joined by Ana Cochino (EMA, Amsterdam, The Netherlands), John Concato (US FDA, Silver Spring, USA), Gracy Crane (Roche Products Limited, Welwyn Garden City, UK) and Laurie Lambert (CADTH, Ottawa, Canada) in the second session of the day. They will discuss how fit-for-purpose decisions are made in practice, and how study questions and data quality can impact these decisions.

Session 3: Transparency in Real-World Evidence: Ensuring Credibility and Confidence

Richard Willke of ISPOR will lead this session that will explore how healthcare decision makers can gain trust in RWE through the appropriate conduct in RWE studies. The discussion will include Adam Aten (Duke-Margolis Center for Health Policy, Bethesda, USA), C. Daniel Mullins (University of Maryland School of Pharmacy, Baltimore, USA) and Shirley Wang (Brigham and Women’s Hospital, Harvard Medical School, Boston, USA), who will guide attendees through the principles for using best practices for study protocols, such as standardization, preregistration, and master protocols, to improve the credibility of study results.

Session 4: Navigating the Real-World Evidence Landscape – Successes, Struggles, and the Path Forward

In the last session of the Summit, specific use cases of RWE for regulatory and HTA purposes will be discussed, with the emphasis on both data and analytics issues. The multistakeholder panel will be moderated by Nancy Dreyer (IQVIA Real World Solutions, USA) and include Stephen Duffield (NICE, Liverpool, UK), Wim Goettsch (National Health Care Institute (ZIN) and Utrecht University, Diemen, The Netherlands), Ashley Jaksa (Aetion, Inc., Boston, USA) and Tae Hyun Jung (Center for Drug Evaluation and Research, US FDA, Rockville, USA).

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