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

Another area of interest is clinical trial-embedded interviews, which are increasingly used to understand the patient experience, in addition to COAs. The ICH guidelines could consider the utility of such trial- embedded qualitative research and how such data might be used by regulators. In the context of vaccines development, patient-reported outcome (PRO) measures are also important. There are some specificities associated with the application of PROs in the context of vaccine development, which should be considered. To have a deeper understanding of the background of using PROs in vaccine development programmes, we reference and provide a link (https://www.tandfonline.com/doi/full/10.1080/2164551 5.2021.1875762) to the following publication: Curran D, Sabater E and Nelsen L. .2021 “Patient Reported Outcomes in Vaccines: Relevance for Decision Making” Human Vaccines & Immunotherapeutics , Volume 17 Issue 9. The paper mentions that guidances should start after substantial completion of existing guidances such as the FDA PFDD guidance and IMI Prefer work. It would be helpful to also discuss specific areas of alignment and any areas that may expand upon current work. To the extent that guidances can be harmonised globally would be helpful in terms of implementation.

Discuss how ICH guidances may align, harmonise, or build upon existing guidances.

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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