dc.contributor.author
Herrmann, Carolin
dc.contributor.author
Kluge, Corinna
dc.contributor.author
Pilz, Maximilian
dc.contributor.author
Kieser, Meinhard
dc.contributor.author
Rauch, Geraldine
dc.date.accessioned
2022-11-30T12:26:58Z
dc.date.available
2022-11-30T12:26:58Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/37107
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-36820
dc.description.abstract
Sample size calculations in clinical trials need to be based on profound parameter assumptions. Wrong parameter choices may lead to too small or too high sample sizes and can have severe ethical and economical consequences. Adaptive group sequential study designs are one solution to deal with planning uncertainties. Here, the sample size can be updated during an ongoing trial based on the observed interim effect. However, the observed interim effect is a random variable and thus does not necessarily correspond to the true effect. One way of dealing with the uncertainty related to this random variable is to include resampling elements in the recalculation strategy. In this paper, we focus on clinical trials with a normally distributed endpoint. We consider resampling of the observed interim test statistic and apply this principle to several established sample size recalculation approaches. The resulting recalculation rules are smoother than the original ones and thus the variability in sample size is lower. In particular, we found that some resampling approaches mimic a group sequential design. In general, incorporating resampling of the interim test statistic in existing sample size recalculation rules results in a substantial performance improvement with respect to a recently published conditional performance score.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
adaptive group sequential design
en
dc.subject
clinical trial
en
dc.subject
sample size recalculation
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Improving sample size recalculation in adaptive clinical trials by resampling
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.doi
10.1002/pst.2122
dcterms.bibliographicCitation.journaltitle
Pharmaceutical Statistics
dcterms.bibliographicCitation.number
6
dcterms.bibliographicCitation.originalpublishername
Wiley
dcterms.bibliographicCitation.pagestart
1035
dcterms.bibliographicCitation.pageend
1050
dcterms.bibliographicCitation.volume
20
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.funding
DEAL Wiley
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
33792167
dcterms.isPartOf.issn
1539-1604
dcterms.isPartOf.eissn
1539-1612