gms | German Medical Science

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)

Artikel

Artikel empfehlen

introduction to dose escalation in early oncology trials and regulatory aspects

Meeting Abstract

Suche in Medline nach

  • Lukas Aguirre Davila - Paul-Ehrlich-Institut, Langen, 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. 489

doi: 10.3205/20gmds024, urn:nbn:de:0183-20gmds0249

Veröffentlicht: 26. Februar 2021

© 2021 Aguirre Davila.
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

Early studies in oncology are often designed to find the dose to be further evaluated in the clinical development program. Such trials are exploratory, and are mainly focused on safety aspects. Uncertainties at the planning stage are encountered with flexible designs and continuous evaluation of analyses during the conduct of the study. This is challenging for sponsors as well as regulators who have to find a balance between adaptability and prespecification. The talk will give a brief introduction to basic methods to guide dose escalation in light of the regulatory perspective.

The authors declare that they have no competing interests.

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