Translating COAs for Multinational Trials Without Unjustified Pooling
Operationalize COA translation and cultural adaptation in multinational trials, from respondent debriefing to the statistical evidence required to pool endpoint data.
22 minBy
Topic
clinical-outcome-assessments
Patient, clinician, observer, and performance outcome assessments.
COA Measurement Properties: Evidence a Trial Still Needs
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.
20 minBy
How to Construct a COA Endpoint Under Draft PFDD Guidance 4
How clinical trial teams construct endpoints from fit-for-purpose COAs and prespecify meaningful-change interpretation plans under draft PFDD Guidance 4.
21 minBy
Content Validity for Trial Endpoints: Using PFDD Guidance 2 to Identify What Matters
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.
23 minBy
PRO, ClinRO, ObsRO, or PerfO: Choosing the COA Type for the Concept of Interest
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.
20 minBy
Fit-for-Purpose COAs: Using FDA PFDD Guidance 3 to Select or Modify an Instrument
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 minBy
