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

researchers across all stages of the research process, where research decision making is guided by patients’ contributions as partners, recognizing their specific experiences, values, and expertise.” Rachel L. Harrington, Maya L. Hanna, Elisabeth M. Oehrlein, Rob Camp, Russell Wheeler, Clarissa Cooblall, Theresa Tesoro, Amie M. Scott, Rainald von Gizycki, Francis Nguyen, Asha Hareendran, Donald L. Patrick, Eleanor M. Perfetto, Defining Patient Engagement in Research: Results of a Systematic Review and Analysis: Report of the ISPOR Patient-Centered Special Interest Group, Value in Health, Volume 23, Issue 6, 2020, Pages 677-688, ISSN 1098-3015, https://doi.org/10.1016/j.jval.2020.01.019.

sought except that the methods for identifying, collecting, and analysing what is meaningful to patients, are not standard or harmonised. Similarly, systematic studies of patient preferences may not be necessary in many clear-cut situations but when they are, it would be beneficial that the methods follow agreed standards. On possible definition of patient focused research could be “The active, meaningful, and collaborative interaction between patients and researchers across all stages of the research process, where research decision making is guided by patients’ contributions as partners, recognizing their specific experiences, values, and expertise.” We suggest to add that: " Even if the patients' comments and suggestions are sought and collected, their integration into development plans remains voluntary. Therefore, there is no mechanism to assess whether the patients' views have been indeed taken into account for the improvement or finalisation of such plans ". It could be helpful to add an example to contextualize the sentence

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20-24 A

We agree with this approach. Nonetheless, there is an omission regarding the actual integration of the patients' views into development plans.

The sentence "...studies of patient preferences may not be necessary in many clear-cut situations…" It would be beneficial to provide explanations for and examples of “clear-cut situations” and “study quality”.

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22-23 A

13

23-24

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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