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

Clinical Trials to Better Measure the Patient Experience – https://www.focr.org/sites/default/files/Comparative%20 Tolerability%20Whitepaper_FINAL.pdf) PRO alerts and electronic PRO use: Patient-Reported Outcome Alerts. Ethical and Logistical Considerations in Clinical Trials – https://jamanetwork.com/journals/jama/article- abstract/1741830 Management of Patient-Reported Outcome (PRO) Alerts Currently, CPROR is working on the development of a guidance on the ethical considerations for the use of PROs in research and routine practice. The guidance is being developed according to the Guidelines for Reporting Health Research by the EQUATOR Network. Our recommendations might be a helpful point of reference when developing ICH guidelines in this area. An announcement piece has been accepted for publication in Nature Medicine. Cruz Rivera S., Mercieca-Bebber R., Aiyegbusi L. O., et al. “The need for ethical guidance for the use of Patient-Reported Outcomes (PROs) in research and clinical practice”, Nature Medicine, 2021 (in press). The reflection paper is very well written, structured and covers the key-issues to prepare the implementation of an important, novel instrument in drug development. The topic is complex and so will be the process. As mentioned in the reflection paper, it is crucial that this endeavour is in Clinical Trials: A Cross Sectional Survey. – https://doi.org/10.1371/journal.pone.0144658

6

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

Page 6/60