• Pauline Lavigne

Patient Reported Outcomes Validity and Valuation

Saturday, December 5th: 7:00 – 9:30 pm

Stayed logged on following the Keynote lecture, to hear this exciting session on patient-reported outcomes (PROs). While PROs should be one of our top priorities, they tend to be secondary or exploratory, tagged on outcomes. From our patients’ perspectives, how they feel and the quality of their surviving years, can be just as, or sometimes more important, than the duration of survival.

This session is chaired by Dr. John Spertus and Dr. Diane Whalley. Dr. Spertus is the Chair in Metabolic and Vascular Disease Research and Clinical Director of the Departments of Biomedical and Health Informatics at the University of Missouri-Kansas City, USA. Dr. Whalley is the Executive Director of Patient-Centered Outcomes Assessment at RTI-Health Solutions, a non-profit organization providing research and consulting services in health economics, patient-centered outcomes research, market access, epidemiology, and clinical research services.

Why do we continue to have issues with PROs? This session will try to answer that question. Topics will include issues around the design, statistical analysis, validation, and interpretation of clinical trials with PROs. We will hear about the use of PROs and mobile health technologies in trials such as METEORIC, ISCHEMIA, and ORBIT.

Joining the co-chairs are Adrian Hernandez (Durham, USA), Suzanne Arnold (Kansas City, USA), Michael Felker (Durham, USA), and Daniel Mark (Durham, USA). We will also hear the patient viewpoint from Jeff Sloan (Rochester, USA), and Patricia Vlasman (Amsterdam, NED); the regulatory viewpoint from Elektra Papadopoulos (FDA, USA), and Emmanouil Zouridakis (MHRA, GBR); the payers viewpoint from Joseph Hutter (CMS, USA), Susan Mills (Brighton, GBR); and the viewpoint of industry from Gary Globe (Amgen, USA).

With this diverse panel, the moderated multi-stakeholder expert panel debate should be highly educational, and more importantly a lot of fun.

The Future of HFrEF Trials

Monday, December 7th: 1:30 – 3:30 pm Therapy for heart failure with reduced ejection fraction (HFrEF) is constantly evolving. Despite the use of beta blockers, ACEIs, ARBs, sacubutril/valsartan, miner

Global Cardio    ascular

Clinical Trialists Forum


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