The journal of clinical outcome assessment operations
Topic
Clinical trial design and execution.
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.
Operationalize COA translation and cultural adaptation in multinational trials, from respondent debriefing to the statistical evidence required to pool endpoint data.
After a named COA is chosen, which reliability, construct-validity, and ability-to-detect-change results still support using that score as a trial endpoint.
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 for clinical development and biostatistics teams on FDA, EMRN V02, and ICH E6(R3) Annex 2 rules for collecting trial endpoints away from traditional sites.
A methodological guide to identifying critical-to-quality endpoint factors under ICH E8(R1) and locking definitions, estimands, and feasibility before protocol freeze.
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.
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 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).
