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

researchers). Patients should not just be ‘involved’ but become an expert source of equal standing to other stakeholders during this process. Methodologically, this process should be based (or at least include) a series of interviews, focus groups and Delphi processes, groupwork sessions with patients and physicians, etc. to identify issues or topics that should be addressed. Furthermore, to agree about the way in which these topics will be measured. Following this stage, questionnaires can be designed and presented to the participants for validation - respondent validation process. Feedback should be taken into account and modifications should be made. Measures that have resulted after such a process could be used in clinical trials. In order to capture meaningful changes overtime, however, it should be stressed that treatment cannot just focus on absence of symptoms but on getting patients to feel as healthy as can be, given their diagnosis. In order for this to be relevant and appropriate for different cultural contexts, the processes described need to be conducted in the same, similar settings or a range of settings. Analyses for validation, reliability are of course needed and translations should be done following appropriate methods (i.e., forward- backward translation). The WHO QOL-100 development process could be used as a reference for the outline of such a process where many stages of development were followed to develop a QoL measure, appropriate for many cultural contexts or allowing for cultural differences [https://www.who.int/mental_health/media/en/76.pdf]. Beyond the use and development of standardized questionnaires, other patient-centric approaches could also be encouraged in order to get qualitative insights based on well adopted design paradigms (e.g. "Design Thinking", User-Centred Design etc.) In addition to the collection of patient information (information flow from patients to physicians), it is important that there is information flow from physicians/scientists/researchers to patients, so that patients can be

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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