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

engagement, conducting patient engagement and reporting & evaluation. Similarly, there is a lack of references to ongoing or completed guidance documents (e.g., the FDA PFDD Guidance I, published in June 2020). With great pleasure we at Kaiku Health Ltd acknowledge the EMA/CHMP/ICH initiative to renew the international GCP guidelines. Especially we want to praise the aim to advance patient focus in drug development. The traditional very much (surrogate) efficacy parameter based clinical trials have focused to disease outcomes, in cancer care, to the cancerous disease burden and/or to the tumor. The patient has been a rather passive provider of information on eg. Adverse events and quality of life data, if asked. Thus, the best provider for data on the real effectiveness of the treatment has been in shadows. What matters most to the patients and to the society is the real value of the treatment; both in humane and economical terms. Many new and very expensive drugs enter the market and clinical use with rather limited efficacy results based on surrigate markers only, which as such, may not fulfill the expectations and values of the patients. The statements here by the representatives of Kaiku Health Ltd concern mainly cancer treatments and patients suffering from cancer. About Kaiku Health and what we have done in this field.

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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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