Clinical Research and GCP Update

ICH Reflection paper : Proposed ICH Guideline to Advance Patient Focused Drug Development

• Proposal endorsed 18 Nov 2020 • Out for consultation 07 Mar 2021 • New ICH guideline addressing what to measure in a clinical trial, including refining the set (list) of important impacts and concepts from patients, to select, modify or develop clinical outcome assessments (COAs) • New ICH guideline addressing methods for elicitation/ collection, analysis, reporting and application of qualitative or quantitative assessments

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EU Clinical Trial Regulation 536/2014

“Involvement of patients or patient’s organisations”. Whereas 18; Article 2.2.11; Annex I 17.e

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