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

post-marketing trials, and drug withdrawals as patients´ voice is heard in early phases of trials. To add actively collected patient reported symptoms to the trials from phase I, would complete ICH´s proposed reliable data generation by a new strategy and action for effectively and efficiently supporting quality in studies. Reliability and validity are well-established terms in quantitative analysis, but not as clear in qualitative analysis. Since the paper is open to qualitative analysis, it might be best to use more generic terms when talking about research in general, e.g., trustworthiness, rigour, bias-free. add a line regarding the fact that regulators and drug sponsors should ensure that documents they use, and the outcome of the research should be made available for patients, caregivers and the broader community in a language which they can easily understand. Feasibility of collection should also be addressed. An additional point needs to be added further below, as the collection of reliable data implies that expert patients are identified and involved in such consultation processes, in collaboration with patient associations (if any) and/or treating physicians.

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See previous column.

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Add: “All information should be made available for patients in a language which they can easily understand”. The feasibility/practicalities of collecting patient perspective data should also be considered. We suggest to add the following: " ensure the information collected derives from expert patients, i.e. people who know in-depth the pathophysiology, clinical expression, complications and multi- disciplinary management of their disease and are familiar with drug development processes, policies and other such documents that affect the health and quality of life of patients at the national, regional and international levels ". Include a line acknowledging potential differences of patient perspective that may relate to disease stage or severity

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In the context of cancer – for example – and for other conditions, it may go beyond ‘same disease’ to stages of a disease – i.e. patient perspectives of

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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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