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

trials, would be acceptable by regulators. In our experience, patient preference data collected outside of a clinical trial can be combined with clinical data to provide valuable insights into patients’ treatment preferences that can inform the interpretation of clinical data (e.g., benefit-risk trade off). General comments that apply to both guidance documents: Industry would welcome more clarity on the following aspects in the finalised guidelines: • “Robustness” criteria for regulatory and payer decision making. • “Overview of quality standards” to help understand and differentiate study quality (and raise overall evidence generation standards). • Definition of “Patient Experience Data (PED)” to help align diverse perspectives (e.g. creating a Global Taxonomy). While it is anticipated that COAs and patient preferences will be explored in two separate guidance documents, COAs and patient preferences are complementary, and both provide valuable information about the patient experience. We suggest that this position is reflected in the guidance documents and recommendations on an approach how both can be used in a complementary manner is explored. Further, it would be valuable to

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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