<oai_dc:dc xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/ http://www.openarchives.org/OAI/2.0/oai_dc.xsd">
  <dc:creator>Gsponer T</dc:creator>
  <dc:creator>Gerber F</dc:creator>
  <dc:creator>Bornkamp B</dc:creator>
  <dc:creator>Ohlssen D</dc:creator>
  <dc:creator>Vandemeulebroecke M</dc:creator>
  <dc:creator>Schmidli H</dc:creator>
  <dc:date>2014</dc:date>
  <dc:description xmlns:ns0="xml" ns0:lang="en">Bayesian approaches to the monitoring of group sequential designs have two main advantages compared with classical group sequential designs: first, they facilitate implementation of interim success and futility criteria that are tailored to the subsequent decision making, and second, they allow inclusion of prior information on the treatment difference and on the control group. A general class of Bayesian group sequential designs is presented, where multiple criteria based on the posterior distribution can be defined to reflect clinically meaningful decision criteria on whether to stop or continue the trial at the interim analyses. To evaluate the frequentist operating characteristics of these designs, both simulation methods and numerical integration methods are proposed, as implemented in the corresponding R package gsbDesign. Normal approximations are used to allow fast calculation of these characteristics for various endpoints. The practical implementation of the approach is illustrated with several clinical trial examples from different phases of drug development, with various endpoints, and informative priors.</dc:description>
  <dc:identifier>https://sonar.ch/global/documents/180</dc:identifier>
  <dc:language>eng</dc:language>
  <dc:relation>info:eu-repo/semantics/altIdentifier/doi/10.1002/pst.1593</dc:relation>
  <dc:relation>info:eu-repo/semantics/altIdentifier/pmid/24038922</dc:relation>
  <dc:source>Pharmaceutical statistics. - 2014</dc:source>
  <dc:subject xmlns:ns1="xml" ns1:lang="en">Bayesian inference</dc:subject>
  <dc:subject xmlns:ns2="xml" ns2:lang="en">adaptive design</dc:subject>
  <dc:subject xmlns:ns3="xml" ns3:lang="en">group sequential design</dc:subject>
  <dc:subject xmlns:ns4="xml" ns4:lang="en">gsbDesign</dc:subject>
  <dc:subject xmlns:ns5="xml" ns5:lang="en">operating characteristics</dc:subject>
  <dc:subject xmlns:ns6="xml" ns6:lang="en">prior</dc:subject>
  <dc:subject xmlns:ns7="xml" ns7:lang="en">Bayes Theorem</dc:subject>
  <dc:subject xmlns:ns8="xml" ns8:lang="en">Clinical Trials as Topic</dc:subject>
  <dc:subject xmlns:ns9="xml" ns9:lang="en">Crohn Disease</dc:subject>
  <dc:subject xmlns:ns10="xml" ns10:lang="en">Drug Discovery</dc:subject>
  <dc:subject xmlns:ns11="xml" ns11:lang="en">Humans</dc:subject>
  <dc:subject xmlns:ns12="xml" ns12:lang="en">Research Design</dc:subject>
  <dc:title xmlns:ns13="xml" ns13:lang="en">A practical guide to Bayesian group sequential designs.</dc:title>
  <dc:type>http://purl.org/coar/resource_type/c_6501</dc:type>
</oai_dc:dc>
