ISPOR Good Practices Task Force on Patient Reported Outcomes (PROs) in Prospective Real-World Studies – Definitions, Value to Stakeholders and Emerging Good Practices

Global regulators, health technology assessors, and policy makers have indicated that patient reported outcome (PRO) data can provide valuable information on the effectiveness, safety and tolerability from the patient perspective. However, no guidance exists on its PRO data use in real world (RW) studies. This task force was undertaken to address the gap.

Speakers will present the scope of its work, identify emerging good practices and provide an example of real world patient reported outcomes (RW-PROs) to regulators.

Audience discussion will be a large component of this session. Feedback is sought on: 1) the emerging good practices for RW-PRO data collection and use; 2) audience case examples of RW-PRO data uses from regulatory, industry and clinical care and 3) the requirements for this data to be acceptable from multi-stakeholder perspectives.

Moderator: Angela Rylands, PhD, CPsychol, Kyowa Kirin International plc, UK, Marlow, London, UK

Discussants: Onyekachukwu Illoh, OD, MPH, U.S. Food and Drug Administration, Silver Spring, MD, USA; Antony Martin, PhD, MSc, BSc, HEOR Director, QC Medica, Liverpool, UK; Konrad Maruszczyk, MSc, MA, Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK