The journal of clinical outcome assessment operations
COA Instruments
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.
· · 10 min read
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Evidence before assertionAn 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.
A step-by-step implementation checklist for clinical development and biostatistics teams to align trial endpoints, computerized systems, and data governance with finalized ICH E6(R3) standards.
