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

acknowledge that while COAs and patient preferences allow for the collection of patient experience data, PED themselves cover a broader field. As stated in the document, line 87-89, “not everything identified as important by patients, caregivers and clinicians is measurable” and the question, line 57, “what disease effects and treatment burdens matter most to patients” is a critical one to be answered including with qualitative data. We also believe that the future guidance should adopt a more holistic perspective and incorporate patient experience to inform not only regulatory decision making but also value assessment decision-making processes (i.e. Health Technology Assessment). Convergence with the HTA approach to patient experience data, by involving HTA representatives in guideline development, should be sought. We also support the proposal to revise ICH M4E and ICH M8 to harmonize regulatory requirements for reporting and submission of patient experience data to regulatory authorities. We recognise your work on reflecting other outputs (e.g. FDA) to optimise synergies while drafting this guideline to ensure development of genuine international guidance to advance patient focused drug development.

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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