The journal of clinical outcome assessment operations
Topic
Primary, secondary, exploratory, and safety endpoints.
How clinical trial teams write executable endpoint definitions in ICH M11 Section 3, integrating SPIRIT-Outcomes elements and aligning Sections 1.3, 7, 8, and 10.
How clinical trial teams construct endpoints from fit-for-purpose COAs and prespecify meaningful-change interpretation plans under draft PFDD Guidance 4.
How clinical development teams can evaluate FDA's surrogate endpoint table across indication, mechanism, and approval pathway without conflating listing with formal qualification.
A methodological guide to identifying critical-to-quality endpoint factors under ICH E8(R1) and locking definitions, estimands, and feasibility before protocol freeze.
A clinical trial guide for reconciling protocol and lab-manual identity when offered substitute collection kits, separating transport compliance from endpoint assay comparability.
A 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 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 guide for clinical development and biostatistics teams to construct ICH E9(R1) estimands, specify intercurrent event strategies, and avoid common missing-data pitfalls.
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 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.
