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

directive approach. The industry should pay for this new research at the expense of present in company research,

radical paradigm shift in the way drug development is conducted.

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The need for an outline of a standardized approach of identifying, collecting and analyzing prioritised, relevant patient perspective including defining a meaningful change are suggested to start after substantial completion of related ongoing work. This can cause huge time delays not serving the high need for the:_ * patients to take their prioritised perspectives into account as well as * pharmaceutical industry to increase their success of a new medicine. Patient and public involvement (PPI) is essential in the development and conduct of PRO research. The research protocol should include PPI. The research publication should state how PPI was used throughout the research. It’s also important that the extent to which translated and culturally validate PROMs are used in clinical trials should be clear. Reasons for not including wider ethnic groups should be made transparent in protocols and publications. It is also important that ethnic groups are included in the development of PROMs. A paper by Dr A.L. Slade entitled "Systematic Review of the Use of Translated Patient Reported Outcome Measures in Cancer Trials" (currently under review by BMC Trials) found that minority groups are underrepresented in cancer trial research where PRO were used as primary or secondary outcomes. The review found that ethnicity groups were not reported and the extent to which translated and culturally appropriate measures were used to capture PRO data was not transparent. Few trials reported collection of data by ethnic groups despite many of the studies being multi-centered and multi-national. Secondly, none of the trials including the multinational studies reported using translated PROMs, although participants stated in qualitative interviews that they were used. This was not clear in either the protocols or published

change to "t hat the outlined work should be started soonest possible in parallel with completion of the related ongoing ICH work. Avoidance of any duplication of content should be carefully ensured",

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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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