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

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There are number of published methodological studies based on international consensus focused on the use of PROs. These publications should be consulted when developing the methods section of the ICH guideline. Reference list: SPIRIT-PRO – Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols. The SPIRIT-PRO Extension – https://www.spirit- statement.org/wp-content/uploads/jama_Calvert_2018_sc_170006.pdf CONSORT-PRO – Reporting of Patient-Reported Outcomes in Randomized Trials. The CONSORT PRO Extension - https://jamanetwork.com/journals/jama/fullarticle/1656259 SISAQOL – International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium – https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30790- 9/fulltext SISAQOL – Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials – https://doi.org/10.1177%2F1740774518795637 SISAQOL – Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards – https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30510- 1/fulltext PROTEUS Consortium promotes tools to optimize the design, analysis, reporting, and interpretation of PROs in clinical trials – https://more.bham.ac.uk/proteus/ Frameworks developed using the FDA guidance for Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims

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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