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GMDS 2015: 60. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

06.09. - 09.09.2015, Krefeld

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Adaptive Designs in Clinical Trials – An Economic Survey of their Influence on Cost Structures

Meeting Abstract

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  • Marc Urban - Universitätsklinikum Münster, Münster, Deutschland; Zentrum für Klinische Studien Münster, Münster, Deutschland
  • Andreas Faldum - Westfälische Wilhelms-Universität Münster, Münster, Deutschland

GMDS 2015. 60. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). Krefeld, 06.-09.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocAbstr. 217

doi: 10.3205/15gmds122, urn:nbn:de:0183-15gmds1225

Published: August 27, 2015

© 2015 Urban et al.
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

Text

Adaptive sequential designs have become very popular in clinical trials over the past few years. Besides methodical challenges and ethical considerations, usually controllability and time saving are mentioned as the main impact and advantage of adaptive trial designs. These characteristics have been intensively investigated during the last decades.

In addition, an intense discussion about costs is taking place and escalating in the public health care sector as well as in the pharmaceutical industry in recent years. In this setting capital is limited and stakeholders are asking for new ideas and methods for the future.

Therefore, a set of three investigator initiated trials have been considered to analyze the impact of interim analyses and adaptive modifications on the total costs of the whole process and trial.

Starting with identifying trial specific work load and the consequences of adaptive modifications on each of them different concepts and examples will be discussed.