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.
- 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.
- Achieving Fit for Purpose Data from Wearables for Age-Related Diseases (January 2023)
- Clinical Outcome Assessments in the Asia Pacific Region: Strategy & Implementation (September2022)
- Leveraging the Value of Clinical Outcome Assessment (COA) Data Beyond Labelling (April 2022)
- Patient-Reported Outcomes Webinar 1: What are PROs and HRQOL Tools? (September 2020)
- Patient-Reported Outcomes Webinar 2: Generating PRO Data – and Using It (October 2020)
- Patient Reported Outcomes Webinar 3: Developing New Patient-Reported Outcomes Instruments (October 2020)
- Using Clinical Outcome Assessments (COAs) in Your Research Study Does Not Necessarily Make It Patient-Centric
- Virtual ISPOR Europe 2021: Is “15% of the Scale Range” Universally Applicable to define a small but relevant individual change for Patient-Reported Treatment Benefits?
- Virtual ISPOR 2021 Forum: “15% of the scale range” Universally Applicable to Define “MID” and Clinical Relevance of Patient-Reported Treatment Benefits?
- COA SIG Virtual Workshop: Patient-focused Endpoints: Developing and Analyzing Patient-Reported Outcomes for Optimal Interpretability
- ISPOR Virtual Europe 2020: Expanding COA in 2020 - Guidance in RWE and Improving Communication Between Different Stakeholders
- ISPOR Europe 2019: ISPOR CLINICAL OUTCOME ASSESSMENT SPECIAL INTEREST GROUP - NEW FRONTIERS - VALUING COA DATA AND GUIDING PRINCIPLES FOR RWE
Kathleen Wyrwich, MS, BS, PhD
Bryan Bennett, PhD, BSc
Angela Rylands, PhD, BSc
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
Arinesalingam Gnanasakthy, MSc, MBA
Darcy Holladay Ford
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