Using Clinical Outcome Assessments (COAs) in Your Research Study Does Not Necessarily Make It Patient-Centric


Moderator: Hoda Fotovvat, PhD, Evidera, Bethesda , MD, USA
Speakers: Eleanor M Perfetto, PhD, RPh, MS, University of Maryland School of Pharmacy, VENICE, FL, USA; Katja Rudell, PhD, MSc, Parexel International, LONDON, LON, UK; Kathleen Wyrwich, PhD, Bristol Myers Squibb, St. Louis, MO, USA

Presentation Documents

Many sponsors claim to be patient centric, centered, or focused. However, what exactly does that mean? For example, does having clinical outcome assessments (COAs) in studies of new health technologies make them patient centric? The ISPOR COA and Patient-Centered Special Interest Groups (SIG) aim to provide leadership in alignment between patient centricity and COA development to achieve harmonization among all stakeholders of interest.

In this session, we will define patient-centricity, highlight reasons for using COA methodology in research studies, and describe how this can improve the relevance of new health technologies to patients. Members of the ISPOR community work on new health technologies at various stages of the lifecycle to meet different evidence requirements, and a common theme should be patient centeredness.

The speakers will outline different methodologies and associated regulatory guidance that pertains to COA and drive towards being patient focused to meet their needs. We will discuss how best to use qualitative, quantitative, and mixed methods for appropriately capturing the patient voice, ensuring measured outcomes are patient centered throughout the technology development journey. Case studies will be presented on how patient insights can inform COAs development. Panel members and attendees will discuss and derive a framework for understanding how COA methods can be optimized for authentic patient-centered research in the development of health technologies.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA




Clinical Outcomes

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