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

psychological and ground field experience. How is EMA going to capture what is known from this social science field? Good clinical evaluation of trials and follow up of released medication, increasing use of this new pharmaco- epidemiology discipline, using and developing local scientific knowledge and networking with European projects is needed. For example, it would be good if the industry acknowledge that Hep C and Covid19 research and patients need are not that different but price of treatment clearly differ. The other argument is that primary care team members are also patients, or their family and they also have this experience. One might question a treatment that saves life – cancer treatment – and due to side effects – peripheral neuropathy – impair one convalescence and survival life. A good example was developed previously with the Diabetes UK study, started with a database on diabetes and gradually evolving into research and knowledge. It would be interesting to start a similar approach with patients complaining about fatigue as this is such a common presentation in primary care. The other lesson from Diabetes UK is that science evolves and for instance in Ischemic Heart Condition beta blockers were once life savers according to Cochrane –

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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