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New FDA guidance cites our framework. Here's what that means for digital endpoint strategy
FDA's new guidance on digitally derived measures reinforces a patient-centered approach to digital health technologies in clinical trials and directly cites the "Digital Measures That Matter" framework co-authored by MRT's Managing Director, Christine Campbell.
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Clinical Outcome Assessments and Digital Measures: Choosing the Right Measurement Strategy for Clinical Trials
As patient-centered clinical trials have become a regulatory expectation rather than a differentiator, sponsors have a variety of options to measure treatment benefit. Traditional clinical outcome assessment (COA) methodology now exists alongside electronic assessments (eCOA), wearable sensors, smartphone-based technologies, and other digital health technologies (DHTs).
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Preparing Clinical Outcome Assessments for APAC trials: What sponsors need to plan for
Preparing clinical outcome assessments for APAC trials requires more than translation. Early planning for licensing, cultural adaptation, validation, and country-specific requirements avoids delays, protects data quality, and keeps global studies on track.
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Prof. James W. Varni & the PedsQL™ - 25 years of partnership
The PedsQL™ began as a response to a specific gap: the absence of developmentally appropriate, child-centered measurement tools allowing young patients to reliably report their own experiences. We spoke with Prof. Varni about the origins of the PedsQL™, the principles that have guided its development, and what its global reach has meant for pediatric care.
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Why interpreting data in clinical trials is the new sponsor challenge
As sponsors increasingly combine both COA and DHT data to understand patient experience and disease progression, they face a new challenge of understanding how these measurements fit together.
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Differential Item Functioning in COA Research
An overview of how this concept is applied in research and its relevance for different populations.
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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.