Moderne Studiendesigns und Analysemethoden in der klinischen Forschung View Full Text


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Article Info

DATE

2015-03

AUTHORS

J. Gerß, M. Eveslage, A. Faldum, R. Schmidt

ABSTRACT

BACKGROUND: Progress in the field of medical research requires further development of clinical trial methodology to overcome the challenges resulting from small patient populations and restricted resources. METHODS: Classical single-stage designs with fixed sample sizes do not allow for interim analyses or design modifications. In contrast, adaptive designs adhere to established quality criteria while providing flexibility when conducting a clinical trial. In the face of new discoveries or information collected in the course of a trial, sample size adjustment, the selection of the target population and further design modifications can be performed. This enhances the chance of success of a clinical trial. Besides adaptive designs, classical approaches may be replaced or complemented by Bayesian methods. In a Bayesian approach prior knowledge can be efficiently included and hence the amount of information utilized in statistical analyses is increased. Furthermore, Bayes procedures allow the results of a statistical evaluation to be displayed very clearly. CONCLUSION: Modern approaches, such as adaptive designs and Bayesian designs overcome the challenges in clinical research due to enhanced flexibility and efficiency. In addition, both approaches can be combined. More... »

PAGES

106-112

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00393-014-1450-8

DOI

http://dx.doi.org/10.1007/s00393-014-1450-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1017274071

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/25805512


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