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



Chair-Elect

Angela Rylands, PhD, BSc

International Outcomes Research Director, Kyowa Kirin
Marlow, BKM, Great Britain

Chair

Olivier Chassany, MSc, PhD, MD

Professor, Assistance Publique–Hôpitaux de Paris (AP-HP)
Paris, 75, France

Past Chair

Katja Rudell, MSc, PhD, BSc

Senior Director of Clinical Outcomes Assessments, Parexel
Chittering, CAM, United Kingdom

Working Groups:


Member Engagement

These activities allow for a variety of members to participate and also facilitates disseminating content in Webinars, Journal Clubs, Conference Sessions, etc.

Chair:

  • Ana Maria Rodriguez, PhD, Director, RWE Patient-Centered Endpoints, Center of Excellence, IQVIA

Key Project

Value of Clinical Outcome Assessment Data to All Stakeholders

Co-Chairs:

Bryan Bennett, PhD, BSc

Asset/Indication Lead, Patient-Reported Outcomes Assessment (PROA), Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb
Uxbridge, United Kingdom

Lynda Doward, MSc, BSc

European Head, Patient-Reported Outcomes, RTI Health Solutions
Manchester, United Kingdom

Background and Objectives of Key Project

This key project aims to identify how non-regulatory stakeholders understand COA concepts, how COA data is currently used in their day-to-day activities and gain a better understanding of the value non-regulatory stakeholders place on evidence generated by COA measures.


Questions or ideas? Please send an email to ClinicalOutcomeSIG@ISPOR.org  


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