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Differential Item Functioning in COA Research
As interest grows in ensuring COAs perform consistently across diverse populations, Differential Item Functioning (DIF) is becoming increasingly important.
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Patient Voices in Oncology: Integrating Efficacy, Tolerability & Treatment Experience
This blog explores how a comprehensive assessment of patients’ symptoms, functioning, well-being, and health-related quality of life is pivotal to oncology research.
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Celebrating 20 years of collaboration: A Q&A with assessment publisher GL Assessment
In this conversation with Patrick McGuire, International Business Consultant at GL Assessment, we reflect on what has made the partnership successful, how it has evolved, and why instruments like HADS continue to endure more than 40 years after their development.
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A framework for pediatric HRQoL selection: Evaluating the PedsQL™
This article outlines a practical framework for selecting a pediatric HRQoL instrument, and applies that framework to the Pediatric Quality of Life Inventory™ (PedsQL™).
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Selecting between an actively- or passively-collected COA
Actively and passively collected outcome assessments captured through COAs and DHTs can overlap, complement one another, and in some cases be interchangeable when measuring a concept of interest. Knowing when and how to use each allows sponsors to build a stronger, more meaningful endpoint strategy.
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What the final PFDD guidance means for COA decisions
This blog post highlights what the practical implications are of the FDA's recently released final PFDD guidance, including how the FDA evaluates outcome data in context.
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Celebrating 25 Years of the WLQ: A Q&A with author Dr. Debra Lerner
To mark the WLQ’s 25th anniversary, Mapi Research Trust spoke with its author, Dr. Debra Lerner, about the origins of the instrument and its continued relevance across diverse populations, industries and settings.
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Rethinking endpoints in obesity clinical trials
As obesity rates rise worldwide, clinical trial teams face growing pressure to show treatment benefits that go beyond weight loss alone.
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Access to Digital Health Technologies and Digital Measures
As clinical research evolves, so do patient-centered outcome measures. For over 20 years, ePROVIDE has been a trusted source for COA data, regulatory guidance, and licensing. Now, sponsors can access the same expertise for digital endpoints and health technologies.
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Selecting fit-for-purpose Clinical Outcome Assessments (COAs) using the ePROVIDE databases
Clinical Outcome Assessments (COAs) measure patient health through active tools like PROs, ObsROs, ClinROs, and PerfOs, or passive digital monitoring. Widely used in research and care, COAs guide decisions on drug approval and treatment. Their rapid growth offers valuable options but also makes selecting the right tool challenging.
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Implementing clinical outcome assessments in a patient-centered endpoint strategy
Health authorities like the FDA and EMA have long promoted integrating patient voice into clinical development. Clinical Outcome Assessments (COAs)—including PROs, ClinROs, ObsROs, and PerfOs—are key tools that capture how patients feel, function, and live. Selecting fit-for-purpose COAs that reflect patient priorities and meet regulatory standards is essential for successful endpoint strategies.
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Why developer guidelines are critical for COA digital migration
With the transition from traditional paper questionnaires to electronic versions, it is imperative that eCOAs are designed to meet the same requirements and have the same level of validity.