Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’

Stakeholder no.

Section No.

Comment and rationale

Proposed change / recommendation

o EORTC module development guidelines (https://qol.eortc.org/manuals/)

o ISPOR (Wild D, Grove A, Martin M, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005;8(2):94-104) • Identifying core outcomes o COMET initiative (https://www.comet-initiative.org/) • PRO analysis o SISAQOL/SISAQOL-IMI (https://event.eortc.org/sisaqol/) • PRO reporting o CONSORT-PRO (https://www.equator- network.org/reporting-guidelines/consort-pro/) o SPIRIT-PRO (https://www.equator- network.org/reporting-guidelines/spirit-pro/) • PRO interpretation including meaningful change o ISOQOL psychometrics group and mixed methods group o SISAQOL/SISAQOL-IMI (https://event.eortc.org/sisaqol/)

Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’ (EMA/CHMP/ICH/415588/2020) EMA/194133/2021

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