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

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There is an urgent need to actively include patients in the drug developing process from the very start of it, the latest in the phase where the patients are subjected to the drug. Although important, prolonging survival is not always the ultimate goal the patients see. The trial protocols already should include patients' views on the goals of the particular treatment, especially when the trade of for gaining something is the toxicity one must suffer. Galapagos NV welcomes the ICH’s recent reflection paper on proposed ICH guideline work to advance patient focused drug development. We support the general approach in including valuable patient perspectives to inform drug development programs and related regulatory decision making. In addition to the topics outlined in the current reflection paper we would like to suggest that the topic of Bring Your Own Device technology (BYOD) is also considered in the new guideline. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both support remote patient research and the use of electronic tools to collect patient data. Furthermore, recent research has demonstrated high level of patient acceptance towards using BYOD in clinical trials. However, a lack of clear guidance on the implementation of BYOD in clinical trials is making risk-averse sponsors hesitant in including this mode of data collection in their clinical trials. In our opinion, there is a growing need to address this issue and provide more comprehensive guidance on the use of BYOD for data capture in clinical trials.

We propose that the future ICH guidance, in addition to the proposed qualitative and quantitative methods and the COA types also

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addresses data capture tools and in particular BYOD use in clinical trials.

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Include vaccines development in Topic C

Include a question on vaccines development: can PROs be used in case definitions and/or to trigger identification of cases?

Regarding discovery /development in general - It’s relevant to consider condition, indication and type of therapy. Appropriate endpoints will vary by condition and by treatment, i.e. some treatments,

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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