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

We hope our comments will be helpful in improving this reflection paper and are looking forward to the finalised document. The EORTC would like to congratulate the ICH for their initiative in providing guidance on how to best include the patient’s perspective into the drug development program. We would also like to thank the ICH for the opportunity to review this document. We have reviewed the ICH reflection paper at the EORTC, both from a clinical trial perspective (i.e., the added value of including the patient perspective in EORTC cancer clinical trials) and a measurement perspective (development of patient-reported outcome measures in oncology). We believe putting patient at the center of drug development is essential. Capturing patient preferences is critical and will need to be done using robust methodology generating useful information. Capturing patient preferences will be important to design sound and relevant clinical trials. Investigating patient experience via the collection and analyse of patient reported outcomes during clinical study is a must. Analysing the true impact of a health intervention via meaningful clinical outcome assessments is critical. Nevertheless, it will be important to clarify what will be the new requirements for clinical study sponsors and researchers. It has to be kept in mind that new obligations should aim

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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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