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

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What disease effects and treatment burdens matter most to patients that might be addressed by a medical therapy? (How) does this vary by subpopulation? • Cold symptoms, persistent coughs, abdominal and periods pains including endometriosis, multiple cardiovascular drug regimen – diabetes and ischemic heart disease - and trying to simplify the prescription. Mental health Hypertension and diabetes, hairs related product, respiratory asthma in Afro Caribbean culture Infectious disease including hepatitis, Mental Health in Asian culture. Wellbeing and disease prevention supplement including food supplement. Recreational drug use, including CBD, antispasmodic and muscles relaxant, prescribing in pregnancy and postnatal, prescribing in elderly.

Expand bullet “What would be the best way to measure these effects and how acceptable are these to the patient?” to include Suggestion to add “assess the treatment burdens”

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see comment on lines 25-28

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B

Even though this list is not meant to be exhaustive, the treatment burdens from a patient perpective is an important element to assess as part of an acceptable therapy.

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What would be the best way to measure these effects?

Cost effectiveness technology

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• Patient satisfaction, Quality of life Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011; 20:1727-1736. • Develop further and support existing tests developers – following episode of Covid19 -.

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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