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Special Interest Groups
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Measurement Comparability Between Modes of Administration of PROMs
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Professional Development Resources
- What is the Impact of GDPR on the HEOR Community
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- ISPOR & AACP Joint Webinar – “Tips for Securing a Post-Doctoral Fellowship”
- You Are Creative: Research is the First Step
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- "My ISPOR Story" - Zeba Khan
- "My ISPOR Story" - Lou Garrison
- Replicate, Regulate, and Redefine: RWE Use Cases in the Next Decade - Session 1
- Replicate, Regulate, and Redefine: RWE Use Cases in the Next Decade - Session 2
- Replicate, Regulate, and Redefine: RWE Use Cases in the Next Decade - Session 3
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Professional Development Resources
Mission
To provide leadership in the use of clinical outcome assessments (patient reported, clinician reported, observational reported, and performance outcomes) in HEOR and to encourage harmonization between all stakeholders of interest.
Goal
- Provide a centralized platform to exchange ongoing ideas relating to the development, implementation and validation of clinical outcomes assessments (COA) measures
- Discuss novel ideas by outlining existing evidence gaps in COA measurement science
- To synthesize COA development practices that allow for the use of scientifically rigorous endpoints.
- Expand the current knowledge base and develop new industry standards for COA use as primary or secondary endpoints in a regulated research environment
- Identify new evidence generation opportunities that will benefit the research, clinical, and patient communities
Background
The FDA defines a clinical outcome assessment (COA) as “a measure that describes or reflects how a patient feels, functions, or survives.” The four types of COAs are: clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), patient-reported outcome (PRO), and performance outcome (PerfO). To see the FDA’s and NIH’s definition of each type, click here.
The growing use and increasing scrutiny of COA measures in pharmaceutical research has led to a need for more precision in the generation and interpretation of such data. Indeed, if the outcomes research literature is reviewed, it demonstrates an almost exponential growth in the development and use of COA measures in drug/medical device research. Those working in the pharmaceutical, medical devices, and diagnostics industries rely upon robust and valid ways to collect COA data. Yet there are few standardized COA measures across stakeholders, due to the ongoing challenges that surround robust COA data capture, analyses, and interpretation.
Leadership
Katja Rudell, MSc, PhD, BSc
Olivier Chassany, MSc, PhD, MD
Working Groups:
Key Project
Value of Clinical Outcome Assessment Data to All Stakeholders
Co-Chairs:
- Lynda Doward, MRES, European Head, RTI-Health Solutions, UK
- Bryan Bennett, PhD, WWHEOR Asset/Indication Lead, Bristol-Myers Squibb, UK
Member Engagement Project: Standardizing Clinical Outcome Assessments for Real World Studies
Co-Chairs:
- Angela Rylands, PhD, Senior International Outcomes Research Manager, Kyowa Kirin, UK
- Ana Maria Rodriguez, PhD, Director, RWE Patient-Centered Endpoints, Center of Excellence, IQVIA