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

meaningful change in a patient over time is best defined by the patient him/herself. How to define meaningful change in a patient over time? – suggest changing “in” to “for” Extra bullet to be added to ensure the right measurements can create any evidence based data supporting any patient perspectivemtext in the Product Information. Even it is mentioned that the indicated questions are not exhaustive, the topic is significant important to think in from early on to be able to get an authority approved, qualitative patient perspective statement in he final Product Information. If not indicated as a visible bullet, it is frequently postponed in the clinical development programme often causing too weak justification for authorities to accept a qualitative patient perspective statement in approved Product Information. Questions regarding patient preference may also include “how patients should be informed”; e.g., by the Sponsor, a GP, a specialist, and is it done in writing (on the layman language) and/or in a conversation such as before accepting a clinical trial.

How to define meaningful change in for a patient over time? Additional bullet after line 63 and before line 64: “* Consider from early on throughout the development process wording on patient perspectives in the Product Information (e.g. SmPC and PIL) supported by meaningful, clinical, relevant data”

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63-64 9

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B

A bullet on “How patients should be informed” could be added

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consider patient subgroups

Add a bullet point: “are there specific patient subgroups to consider?” How can patient preference data be used beyond understanding benefit-risk trade- offs? (e.g., understanding the relative importance of other aspects of treatment

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We acknowledge that on line 71, it is mentioned that this is not an exhaustive list. However, we recommend including at least one example in the list that demonstrates a use of patient preference data beyond benefit-risk trade-offs. An example of a possible additional bullet point is proposed below.

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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