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

papers. Qualitative interviews highlighted significant barriers to the use of translated and culturally validated PROMs, including: availability of measures; insufficient resources and training; investigator burden; and administrative difficulties associated with collecting different versions. The dearth of reporting in both protocols and publications raises several issues and questions: 1) The extent to which patients were excluded because of language barriers was not transparent, 2) The extent to which translated and culturally validated PROMs were being used was not clear, as it was not reported in protocols or publications. This raises concerns that data collected in clinical trials is under representative of ethnic minorities and results may not be applicable to all ethnic groups. This is especially important as ethnic groups often present later and with more advanced health problems. Moreover, following paper provide important insight into PPI: “Give Us The Tools!” - Development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT- PRO Extension (currently in press by BMJ Open) Moving beyond project-specific patient and public involvement in research - https://journals.sagepub.com/doi/10.1177/0141076819890551 The specifics on “how” is most important here, thus input on the guidelines proposed as next steps will be crucial.

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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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