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

There may be reservations about involving individual patients in collaborative activities with stakeholders on grounds that their input will be subjective and open to criticism. However, EUPATI, in line with regulatory authorities, instils the value of equity by not excluding the involvement of individuals. It should be left to the discretion of the organisation/s initiating the interaction to choose the most adequate patient representation in terms of which type of patient for which activity (see section 7). Where an individual patient will be engaged it is suggested that the relevant patient organisation, where one exists, be informed and/or consulted to provide support and/or advice. The type of input and mandate of the involved person should be agreed in any collaborative process prior to engagement.

2

0

A significant amount of patient input (the majority?) may be qualitative data. It may be helpful to have more clarity about what kinds of qualitative data, with what criteria of robustness, trustworthiness, etc., are preferable in general and specifically/especially within clinical trials...but this may be for a later step in this process. It is appreciated that the ICH reflection paper clearly recognises the importance of global alignment and that future guidance intends to make optimal use of existing initiatives. Overall: A high appreciation for ICH taken the initiative to acknowledge the importance of having patients perspectives integrated in medicines discovery and

3

4

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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