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

pharmaceutical industry. Update of the ICH M4E (CTD), ICH M8 (eCTD) and E6(R3) (GCP) are also important to take the integration of patient perspectives into account. Please ensure patients are involved in those future related ICH updates and/or developments. For the below, specific comments Nos. 3-6 are very important to take into account from a patient advocate perspective. Comment No. 2 is categorised as minor,, while the above general, comment No. 1 is categorised as very important, too. Guidelines issued by ICH should be applicable to all disease areas, not just specific to a particular medicine discipline (e.g. oncology – the EMA Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man – https://www.ema.europa.eu/en/documents/other/append ix-2-guideline-evaluation-anticancer-medicinal-products- man_en.pdf). Patient-Reported Outcomes Tools: Engaging Users & Stakeholders PROTEUS (https://www.pcori.org/research- results/2018/proteus-patient-reported-outcomes-tools- engaging-users-stakeholders) The following references around PRO and tolerability should be included to strengthen the guidelines (Broadening the Definition of Tolerability in Cancer

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B

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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