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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.
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NMPA guidance on PROs for rheumatic disease trials in China
China’s NMPA published, in January 2025, new technical guidance on the application of Patient-Reported Outcomes (PROs) in clinical trials for rheumatic diseases.
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The role of Clinical Outcome Assessments in schizophrenia research and treatment
This blog details the growing role of COAs in schizophrenia research, highlights key COAs in this field, and discusses their regulatory recognition.
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The Power of Patient-Reported Outcomes in Labeling Claims
This blog details how Patient Reported Outcomes (PROs) are gaining prominence as a way for pharmaceutical companies to support drug labeling claims.