ISPOR—The Professional Society for Health Economics and Outcomes Research announced its ISPOR Real-World Evidence Summit 2023 scheduled for May 7 in Boston, MA, USA. The Summit is collocated with and being held immediately prior to the Society’s annual international conference, ISPOR 2023. The Summit is a collaboration between ISPOR, the International Society for Pharmacoepidemiology (ISPE), and the Duke-Margolis Center for Health Policy.
The Summit, themed “Making Real-World Decisions with Real-World Evidence: From Frameworks to Practice,” will take attendees behind the scenes to offer an in-depth examination of key issues surrounding real-world evidence (RWE) in regulatory decisions and health technology assessment. Program sessions, centered around data quality and fit-for-purpose use, will delve into studies that showcase the utilization and effectiveness of RWE in healthcare decision-making.
Sessions for the ISPOR Real-World Evidence Summit 2023 include the following with speakers added to the online program as they are confirmed:
Session 1:
From Data Quality to Qualities
The first session of the Summit will examine how data quality is described and measured. Panelists will discuss recent data quality frameworks, developments in validation, and measurement of important aspects of quality. Speakers include:
- Moderator: Rachele Hendricks-Sturrup, DHSc, MSc, MA; Duke-Margolis Center for Health Policy; Washington, DC, USA
- Andre Araujo, PhD; GSK; Philadelphia, PA, USA
- Marni Hall, PhD, MPH; IQVIA; Rockville, MD, USA
- Sebastian Schneeweiss, MD, ScD; Harvard Medical School, Brigham and Women’s Hospital; Boston, MA, USA
Session 2:
Considering Data Qualities in Determining Fit-for-Purpose – Can We Converge on an Approach?
This session will focus on the principles and realities of how fit-for-purpose decisions are made based on the needs of the study question and the qualities of the data. Speakers include:
- Moderator: Marc Berger, MD; Marc L. Berger, LLC; New York, NY, USA
- Ana Cochino, BS; EMA; Amsterdam, Netherlands
- John Concato, MD, MS, MPH; US Food and Drug Administration; Silver Spring, MD, USA
- Gracy Crane, PhD; Roche Products Limited; Welwyn, England, UK
- Laurie Lambert, PhD; Canadian Agency for Drugs and Technologies in Health; Ottawa, ON, Canada
Session 3:
Transparency in Real-World Evidence: Ensuring Credibility and Confidence
This session will explore how good conduct for RWE studies can offer healthcare decision makers with greater confidence in the credibility of study results. Panelists will cover the use of standardized protocol templates, preregistration of study protocols, and the move towards master protocols, with reference to specific tools that are available or in development. Speakers include:
- Moderator: Richard Willke, PhD; ISPOR; Lawrenceville, NJ, USA
- Adam Aten, MPH, MSc; Duke-Margolis Center for Health Policy; Washington, DC, USA
- C. Daniel Mullins, PhD; University of Maryland School of Pharmacy; Baltimore, MD, USA
- Shirley Wang, PhD, MSc; Brigham and Women’s Hospital, Harvard Medical School; Boston, MA, USA
Session 4:
Navigating the Real-World Evidence Landscape – Successes, Struggles, and the Path Forward
This final session of the Summit will include a review of specific cases of RWE use for regulatory or health technology assessment purposes. Panelists will consider both data and analytic issues in their discussions. Speakers include:
- Moderator: Nancy Dreyer, MPH, PhD; IQVIA Real World Solutions; Chapel Hill, NC, USA
- Stephen Duffield, PhD, MD; NICE; Liverpool, England, UK
- Wim Goettsch, PhD; National Health Care Institute (ZIN) and Utrecht University; Diemen, Netherlands
- Ashley Jaksa, MPH; Aetion, Inc; Boston, MA, USA
- Tae Hyun Jung, PhD; Center for Drug Evaluation and Research, US Food and Drug Administration; Rockville, MD, USA
The ISPOR Real-World Evidence Summit 2023 is collocated with and being held immediately prior to ISPOR 2023, the Society’s annual international conference. ISPOR 2023 is scheduled for May 7-10 with the theme, “Impacting Innovation, Value, and Healthcare Decision Making.” ISPOR 2023 requires a separate registration.
ISPOR is recognized globally as the leading professional society for health economics and outcomes research and for its role in improving healthcare decisions. ISPOR Summits draw healthcare stakeholders with an interest in HEOR-related topics, including researchers and academicians, assessors and regulators, payers and policymakers, the life sciences industry, healthcare providers, and patient engagement organizations.
