Bayesian Phase II Single-Arm Designs

Satoshi Teramukai ()
Additional contact information
Satoshi Teramukai: Kyoto Prefectural University of Medicine, Department of Biostatistics, Graduate School of Medical Science

A chapter in Frontiers of Biostatistical Methods and Applications in Clinical Oncology, 2017, pp 65-84 from Springer

Abstract: Abstract Phase II exploratory clinical trials in oncology are often designed as single-arm trialsSingle-arm trial using a binary efficacyEfficacy outcome with or without interim monitoring. This chapter focused on the BayesianBayes/Bayesian designs which considered both efficacy and safety outcomes associated with early stopping. In particular, we introduce a Bayesian adaptive design denoted as predictive sample size selection designPredictive sample size selection design (PSSD). The design allows for sample size selection following any planned interim analyses for early stopping of a trial, together with sample size determination. An extension of the PSSD to add continuous monitoring of safety is also described. We investigate the operating characteristics of the design through simulation studies.

Keywords: Sample size determination; Analysis prior; Design prior; Prior predictive distributions; Sample size re-estimation; Bayesian adaptive design; Predictive sample size selection design; Beta priors; Bayesian conjugate analysis; Predictive probability criterion; Interim monitoring (search for similar items in EconPapers)
Date: 2017
References: Add references at CitEc
Citations:

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-981-10-0126-0_6

Ordering information: This item can be ordered from
http://www.springer.com/9789811001260

DOI: 10.1007/978-981-10-0126-0_6

Access Statistics for this chapter

More chapters in Springer Books from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().