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

A lot of clinical drug development occurs in the very late phase of the disease, ie. in the 3rd t reatment line and beyond, and drugs approved in this setting are eventually also used. What is said about palliative treatment above, is especially true in this setting. Active drug treatment in the last months of a cancer patient's’life is rather common. According to some studies active treatment is given in 10 - –0 % of the cases during the last 30 days before death. This is not only due to clinical imcompetence. It also reflects the twisted expectations both the physicians and the patients have on the capabilities of cancer drugs. Treating false hopes of a patient with toxic substances is nothing but a disservice to everyone. Especially in this setting the patients' ’oice should be heard carefully. What are methodological considerations for sponsor conduct of patient preference studies to provide credible and reliable findings to support regulatory decision making? • Independent from pharmaceutical industry trial, no conflict of interest. Extra bullet to be added to ensure the right methodologies used for measuring the right patient relevant factors can create any evidence based data supporting any patient perspective yext in the Product Information. Even it is mentioned that the indicated questions are not exhaustive, the topic is significant important to think in from early on to be able to get an authority approved, qualitative patient perspective statement in the final Product Information. If not indicated as a visible bullet, it is frequently postponed in the clinical development programme often causing too weak justification for authorities to accept a qualitative patient perspective statement in approved Product Information. Should this refer to "independent" findings as well?

16

69-70

11

70

B

4

70-71 11

Additional bullet after line 70 and before line 71: " * Consider from early on what authority accepted method(s) should be used and what are the minimum size of meaningful, patient relevant perspective data required to support a qualitative, patient staterment in the Product Information (e.g. SmPC and PIL)".

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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