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

Stakeholder no.

Section No.

Comment and rationale

Proposed change / recommendation

collection, analysis, reporting and application of patient- oriented outcomes. As an example, a randomized clinical trial may be blinded to treatment allocation by addition of a placebo drug. This impacts the patients’ perception by adding uncertainty to his/her treatment status and discomfort by requiring to comply to a medication schedule. Our EFPC working group is enthusiast. This is a very relevant step in making pharmaceutical care more adequate and relevant for patients. The paper is for political reasons formulated in an only positive approach. Yet, we would like to hear the problems that make this switch to a clear patient centered approach necessary. It is well known that patient information on many drugs are downplaying the side effects of drugs (e.g. contraceptives, but also A II inhibitors, LUTS-drugs, etc. ) Many drugs also are hardly clinically relevant (e.g. psychopharmaceutics, chemotherapy). The intrinsic problem of the for profit orientation of the industry is often at odds with objective, independent presentation of facts, patient information and even research. If we could agree in this paper on the problem analysis, that would be ideal. But we can see that such an approach would divide and kill this project in its start. Yet it would be in the patients interest, when the research would be totally independent with no ownership by Pharma. It would also be helpful if the information on drugs as well as the text

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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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