The journal of clinical outcome assessment operations
The journal · Page 4
Independent analysis of endpoint strategy, measurement operations, and clinical trial systems.
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.
A methodological guide for clinical development and biostatistics teams to construct ICH E9(R1) estimands, specify intercurrent event strategies, and avoid common missing-data pitfalls.
A methodological guide for biostatisticians and clinical trialists to separate intercurrent events from true missing data and pre-specify same-estimand sensitivity analyses.
A rigorous analysis of multiplicity management in clinical trials, comparing FDA's 2022 final guidance and EMA's 2002 Points to consider across co-primaries, hierarchies, and gatekeeping.
A structured guide for clinical operations, biostatistics, and data management teams to operationalize 21 CFR Part 11 compliance, audit trails, and UAT evidence for eCOA systems.
An evidence-based comparative evaluation of Bring Your Own Device (BYOD), sponsor-provisioned, and hybrid eCOA deployment models across data integrity, psychometrics, and operational costs.
