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

to improve the quality and relevance of drug development but without jeopardizing the conduct of clinical research because of unrealistic expectations We would also like to be included in the development of these guidelines as this topic is of interest to us, both as a PRO instrument developer and an academic clinical trial group. Please find our comments and suggestions below: 1. The guideline stresses the need for standardized methodology for identifying, collecting, and analysing that what is meaningful to patients. However it should be stressed that where appropriate standards already exists (eg. Validated questionnaires, core outcomes, standardized reporting, …) that in these instances the groundwork does not need to be repeated for each new study. More specifically, we would like to highlight following the initiatives and guidelines: • Development and validation of PROs, including elicitation of relevant outcomes o EORTC module development guidelines (https://qol.eortc.org/manuals/) o COSMIN (cosmin.nl) • Translations and translatability of PRO instruments

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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