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

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

07. bis 10.09.2009, Essen

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How to consider events occurring after the pre-specified observational period?

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  • Stefan Hantel - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
  • Erich Bluhmki - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds). Essen, 07.-10.09.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09gmds126

doi: 10.3205/09gmds126, urn:nbn:de:0183-09gmds1268

Published: September 2, 2009

© 2009 Hantel et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

Text

In event driven trials investigating for example new drugs for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), the primary outcome variable is a composite endpoint of recurrent events (e.g., recurrent DVT, PE or VTE related mortality) observed during the pre-specified treatment period. If patients terminate the treatment prematurely, observed events until the planned end of treatment should be included in the primary analysis. However, it is not obvious from the guidelines or publications, whether and how events should be considered, which are observed after the planned end of the treatment period / observational period.

We compare an approach of using only events occurring until the pre-specified cut-off with a procedure using all observed events according to an intent-to-treat principle based on data form controlled clinical trials.

Outline

References

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