Topic

instrument-validation

Evidence supporting instrument validity and fitness for purpose.

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.

Sep 1620 minBy Ran Chen

Editorial still life of an analog balance scale, unmarked assessment booklets, a wooden ruler, and a fountain pen on warm parchment and oxblood linen.

COA Instruments

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.

Aug 2710 minBy Ran Chen

Editorial still life of an unmarked paper assessment booklet, pencil, and unbranded analog timer on parchment with oxblood cloth