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

treatment exist at all, or only symptomatic ones and not disease-modifying ones. Or there is some benefit, but partial only.

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What are patients’ unmet needs that suggest potential drug targets?

• Remedies for Non-medical condition – wellbeing - Vitamin's minerals and over the counter supplements, diets, cold remedies for adults and for children, vaccinations side effects in particular flue or Eustachian Tube dysfunction, nondependent sleeping aids, overweight, abdominal painkillers (Irritable bowel disease, periods delayed or periods pains in particular adolescents, hormonal replacement therapy), muscles and painkillers (Fibromyalgia osteoarthritis), mental health (depressed mood, memory changes). • Occupational diseases. Neurodegenerative diseases – Parkinson, Alzheimer and peripheral neuropathy - Fertility treatment, lungs disease – antenatal conditions, infectious pediatric (postnatal

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56-63 B

Methodological considerations on patient experience data collection, processing and storage should also be included in the drug development process

We would recommend to add one point to the bullet points list after line 63:

- What modalities of patient experience data collection, storage and processing are acceptable? What disease effects and treatment burdens matter most to patients that might be addressed by a medical therapy and/or intervention? (How) does this vary by subpopulation?

Proposal to add “addressed by a medical therapy and/or intervention”, as it could be that the patient believes a device + therapy would be the best combination, so clarifying whether this is just limited to therapies administered on their own or in combo with other interventions may be useful clarity

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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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