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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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Connecting mono and combination dose finding via joint modelling – Theoretical aspects, simulation results and real life

Meeting Abstract

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  • Frank Fleischer - Boehringer Ingelheim Pharma GmbH & Co. KG, Biometrics and Data Science, Biberach, Riss, Germany
  • Daniela Fischer - Boehringer Ingelheim Pharma GmbH & Co. KG, Biometrics and Data Science, Biberach, Riss, Germany
  • Jan Beyersmann - Ulm University, Institute of Statistics, Ulm, Germany
  • Lukas Schroeter - Boehringer Ingelheim Pharma GmbH & Co. KG, Biometrics and Data Science, Biberach, Riss, GermanyUlm University, Institute of Statistics, Ulm, Germany

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. 328

doi: 10.3205/20gmds023, urn:nbn:de:0183-20gmds0231

Veröffentlicht: 26. Februar 2021

© 2021 Fleischer et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.

Gliederung

Text

Within the area of oncology dose-finding several model-based methods for the determination of the maximum tolerated dose (MTD) have been developed. A prominent and widely used approach implements a Bayesian logistic regression model based on the patient-level information of dose-limiting toxicities. A major advantage of this approach is the opportunity to use external data e.g. coming from historical sources or co-data to enrich the data situation and thereby to increase the precision of the MTD estimation. For this purpose, e.g. the meta-analytic prior (MAP) approach and the related meta-analytic combined (MAC) may be used.

In this presentation, we start by introducing the basic BLRM model for the mono and combination therapy case. Next, we will turn our attention to the MAP and MAC models for adding historical and co-data information into the BLRM. A joint modeling approach for the BLRM based on MAC is presented that is able to cope with simultaneous dose escalations in different settings like mono, combo or different combinations. In this approach, the different escalations are simultaneously enriching each other with co-data. We show simulation results regarding simultaneous escalations displaying the potential benefits of a joint modeling approach. Finally, we present a real life example for a trial that simultaneously performs different escalations using such a joint modeling approach.

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