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

trials. • The role of the caregivers: Their role on the wellbeing and understanding of the impact of a treatment on the patient (particularly if the patient is not in a condition to communicate that information) is often underestimated. Could their voice also be considered in such documents? • Diversity and inclusion: EFPIA believe it is of major importance to explicitly address diversity and inclusion in the patient engagement process and noticed the passive reference to the subgroups in the Reflection Paper (RP. The RP does not discuss the issues of patient needs at the level of different communities. Instead, we notice the RP seems to state that all patients, when taken together, have the same levels of access and the same overarching needs and constraints. Of course, we acknowledge that this is maybe more of an issue in the United States than elsewhere, so we acknowledge that addressing this concept in an ICH guideline might be challenging. • Reference to existing guidance documents and initiatives: The RP mentions that there are a range of services, sources etc... in the patient involvement space, with reference to the FDA guidance and IMI PREFER; however it would be useful to also include reference to the co-created IMI PARADIGM Toolbox, which provides recommendations, tools and relevant background information to make patient engagement in medicines development easier for all. This tool box (https://imi- paradigm.eu/petoolbox/) covers planning patient

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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