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65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS)

06.09. - 09.09.2020, Berlin (online conference)

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One year of ICH E9 addendum – regulatory reflections and perspectives

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  • Ina-Christine Rondak - European Medicines Agency, Amsterdam, Netherlands

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS). Berlin, 06.-09.09.2020. Düsseldorf: German Medical Science GMS Publishing House; 2021. DocAbstr. 393

doi: 10.3205/20gmds091, urn:nbn:de:0183-20gmds0913

Published: February 26, 2021

© 2021 Rondak.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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In November 2019, The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and a number of regulatory agencies have published an addendum to the ICH E9 guideline “Statistical Principles for Clinical Trials” [1] on estimands and sensitivity analysis. This addendum aimed at helping to identify the scientific questions of interest for each clinical trial, and as a consequence, to better align its various aspects of planning, design, conduct as well as data analysis and interpretation. It was supposed to foster a better conversation between drug developers and regulators and also between clinicians and statisticians. One year after its publication, reflections on the impact of ICH E9(R1) on submissions to the European Medicines Agency shall highlight its uptake and illustrate remaining open questions.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.

Outline

References

1.
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, Step 5 (EMA/CHMP/ICH/436221/2017)