Ari Gnanasakthy, Principal Scientist, Patient-Centered Outcomes Assessment at RTI Health Solutions, shared on LinkedIn:
“China has rapidly emerged as a major global hub for early-phase oncology drug development, with recent analyses identifying it as a leading location for early-phase oncology trials.
At the same time, there is growing interest in incorporating patient-reported outcomes (PROs) into early-phase oncology trials to inform dose optimization and selection.
But this raises an important question about the generalizability of PRO findings.
Research has demonstrated differential item functioning across cultural and geographic populations, with some of the largest variations observed in East Asia. This suggests that patients from different cultural backgrounds may interpret and respond to the same PRO questions differently, even when their underlying health experiences are comparable.
The issue is not whether patients understand the questions (nothing to do with linguistic validation), but whether their responses carry equivalent meaning when used to inform dose-selection decisions.
As PROs are encouraged to contribute to dose selection, can a dose established using PRO data predominantly from Chinese patients be assumed to be equally appropriate for patients in the US or Europe?
After all, the dose may be global, but the patient experience is not necessarily universal.
Which brings me to a more fundamental question:
Should PROs help define the dose of cancer treatments when the fundamental assumptions underlying their use may not hold across populations?”
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