To provide leadership in the use of COAs (PRO, ObsRO, ClinRO, PerfO) and to encourage harmonization betweeen all stakeholders of interest. 


  • 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 


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.



Kathleen Wyrwich, MS, BS, PhD

PhD, Bristol Myers Squibb
St. Louis, MO, United States


Bryan Bennett, PhD, BSc

Senior Director, Patient Centered Outcomes, Jazz Pharma
Oxford, NBL, United Kingdom

Past Chair

Angela Rylands, PhD, BSc

International Outcomes Research Director, Kyowa Kirin
Marlow, BKM, 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.

Donald Bushnell, MA

Sr. Research Scientist, Evidera
Bethesda, MD, United States

Arinesalingam Gnanasakthy, MSc, MBA

Principal Scientist, RTI Health Solutions
Durham, NC, United States

Darcy Holladay Ford

Director of Research, CIVHC
Denver, CO, United States

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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