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

11. Iivanainen S, Alanko T, Peltola K, Konkola T4 Ekström J, Virtanen H, Koivunen JP: ePROs in the follow-up of cancer patients treated with immune checkpoint inhibitors: a retrospective study. J Cancer Res Clin Oncol (2019) 145: 765. Doi: 10.1007/s00432-018-02835-6 We would welcome a structured process to incorporate the patient preference data into regulatory submission to inform regulatory decision making. Currently the FDA Regulatory Submission Checklist for patient experience data from both clinical trials and non- clinical trials is not a clear roadmap as to what is expected and needed for a 16avourable submission. We would welcome more clarity to provide more transparency. How will the data be scored and ‘coded’ to have utility for programmes in the future? Is there a consideration of transferability of results from one disease state to another? (Eg if disease state 1 had ‘pain’ or ‘sleep disturbance’ as key criteria to be addressed would these data be transferrable to disease state 2?) Standardisation would achieve some consistency of patient experience as they interact with pharma, but how do competitive interests play out in this context? i.e. what level of standardisation is aspired towards?

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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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