UNDERSTANDING THE VALUE AND FEASIBILITY OF ENGAGING PATIENTS IN THE DESIGN OF CLINICAL TRIALS AND CLINICAL OUTCOME ASSESSMENT MEASUREMENT STRATEGIES- INSIGHTS FROM EXPERIENCES IN ONCOLOGY AND GOUT

Author(s)

Bryan Bennett, PhD, Adelphi Values Ltd, Bollington, Cheshire, UK; Stephanie Manson, PhD, Novartis, East Hanover, USA; Katja Rudell, PhD, Queen Mary University of London, London, UK; Sophi Tatlock, MA, Adelphi Values Ltd, Bollington, Cheshire, UK

PURPOSE: The purpose of this workshop is to discuss the value of engaging patients in both clinical trial design and clinical outcome assessment (COA) strategies, as well as examining the types of stakeholders who benefit, by drawing on case study examples. Additionally, the logistical considerations around the feasibility of patient engagement initiatives will be explored. DESCRIPTION: Patient engagement acknowledges that the patient is an expert in their own health and care. Encouraging patient engagement may increase activation, promote positive patient behavior and thereby in turn improving outcomes. The presenters in this workshop will draw upon two case study examples of patient engagement: 1) the development and use of the Clinical Trial Feedback Questionnaire (which Dr. Stephanie Manson and Dr. Bryan Bennett developed); and 2) the engagement of a patient advisory group as well as video evidence in the critical evaluation of COAs in supporting endpoints in gout clinical trials (as conducted by Dr. Katja Rudell and Sophi Tatlock). By engaging patients beyond their traditional ‘passive’ role as subjects in trials, or interview participants in COA validation studies, the presenters will discuss the added value and insights obtained, as well as exploring the range of stakeholders who benefitted, in each case study. Participants will be asked to participate in a discussion around the feasibility of patient engagement, notably the logistical challenges which may need to be considered and how they can be overcome. Throughout the interactive discussions with the audience we will discuss our solutions to logistical challenges with our participants. Participants who attend the workshop will therefore leave the session with experience based innovative methods of engaging with patients in clinical trial design and COA research.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Code

W16

Topic

Clinical Outcomes, Patient-Centered Research

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