The journal of clinical outcome assessment operations
COA Instruments
A methodological guide to FDA PFDD Guidance 2 for trial teams to elicit patient-reported disease and treatment burdens before assuming an existing questionnaire defines the concept of interest.
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Evidence before assertionA structured clinical trial guide for documenting therapy identity, supply responsibility, and actual exposure when routine-care or background regimens encounter insurance coverage delays before biostatisticians classify an intercurrent event.
A methodological decision framework for clinical trialists to select among PRO, ClinRO, ObsRO, and PerfO measures based on the concept of interest and context of use before naming an instrument.
A structured guide for trial endpoint leads, laboratories, and biostatisticians on evaluating endpoint observations after an analyzer service event, separating equipment release from data review and SAP handling under 42 CFR 493, ICH E6(R3), and ICH E9(R1).
A methodological guide for biostatistics and clinical development teams on what endpoint definitions, estimand-aligned estimators, and sensitivity analyses the SAP must lock before unblinding.
A methodological framework for clinical operations, biostatistics, and outcome-assessment teams to qualify, train, and monitor ClinRO raters—preventing endpoint drift without relying on start-up certification alone.
A practical release framework for endpoint and data management leads: separating eCOA measurement alterations from schedule and configuration changes under 21 CFR 312.30, 21 CFR 56.108, final PFDD Guidance 3, and EMA Annex 2.10.
A methodological guide for clinical development and biostatistics teams to evaluate measurement comparability across paper, tablet, smartphone, and web modes under the 2023 ISPOR Task Force rule and October 2025 FDA PFDD Guidance 3.
A practical framework for clinical development and quality teams to validate computerized systems capturing trial endpoints—distinguishing platform qualification from protocol configuration under FDA 2024 and EMA 2023 guidelines.
A practical framework for evaluating clinical outcome assessment fitness for purpose under FDA's final PFDD Guidance 3, spanning instrument selection, modification, and evidentiary rationales.
An evidence-based guide to validating digital health technologies (DHTs) for clinical trial endpoints under FDA's December 2023 guidance, covering verification, validation, and missing data.
