June 3, 2025
Open to all ISPOR Members and Non-members
Title: Global Standards, Real-World Impact: The Role of HARPER
Tuesday, June 3, 2025
10:00AM EDT | 2:00PM UTC | 4:00PM CEST
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The evolution of real-world evidence (RWE) studies is being shaped by an increasing focus on harmonized standards, transparency, and reproducibility. Historically, regulators, payers, and health technology bodies have faced RWE submissions of varying quality and detail. This has slowed review and approval process as well as limited the impact of RWE in decision making. Stakeholders on each side of the table seek predictable and transparent RWE study processes - from study planning and execution through review. HARPER is a harmonized protocol template designed to help investigators thoroughly consider and document conceptual and operational decisions as well as rationale for key study parameters that define the causal question (eg, target estimands). The common text, tabular, and visual structure facilitates reproducibility and helps multi-disciplinary teams know what to look for and where to find it. The template can enable efficient and effective assessment of validity and potential for biases from scientific reviewers that evaluate submitted protocols.
Key global stakeholders have produced guidance that endorses or strongly encourages the use of HARPER for RWE study submissions designed to inform regulatory and reimbursement decisions including guidance from National Institute for Health and Care Excellence (NICE), Canada’s Drug Agency (CDA-AMC), Council for International Organizations of Medical Sciences (CIOMS), European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP), and others. This webinar focuses on the recent M14 guidance from the International Council of Harmonization (ICH) which sets international standards and promotes harmonization of global practices in study planning and execution of RWD studies submitted to international regulatory organizations and the Centers for Medicare and Medicaid Services' (CMS) guidance on RWE to support national coverage determinations within the coverage with evidence development (CED) paradigm.
Learning Objectives
- Understand the importance and relevance of the HARPER protocol template for RWE studies
- Identify the role of key global stakeholders in shaping harmonized study standards
- Examine the implications of the ICH M14 and CMS guidance on RWE studies
Moderator:
Laura Pizzi, PharmD, MPH, Chief Science Officer, ISPOR, Lawrenceville, NJ, USA
Speakers:
Rachele Hendricks Sturrup, DHSc, MSc, MA, Research Director, Duke-Margolis Institute for Health Policy, Washington DC, USA
Steven Farmer, MD, FACC, FASC, Chief Strategy Officer, Centers for Medicare and Medicaid Services, Washington DC, USA
Shirley Wang, PhD, ScM, Associate Professor, Harvard Medical School, Boston, MA, USA
Patrice Verpillat, MD, PhD, Head of Real-World Evidence, European Medicines Agency, Amsterdam, Netherlands
Paul Coplan, MBA, MSc, ScD, Vice President & Head, Epidemiology & Real-World Data Sciences, Johnson and Johnson Medical Devices, Fort Washington, PA, USA
Brought to you by: ISPOR Real-World Evidence Steering Committee
Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.