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Issue Information

Free Access

Issue Information

  • Pages: 287-289
  • First Published: 13 July 2016

Editorial

Statistical methods for the analysis of adverse event data

Meinhard Kieser, 
  • Pages: 290-291
  • First Published: 20 June 2016

Special Issue Papers

Open Access

Biometrical issues in the analysis of adverse events within the benefit assessment of drugs

Ralf Bender,  Lars Beckmann,  Stefan Lange, 
  • Pages: 292-296
  • First Published: 29 February 2016

Statistical issues in the analysis of adverse events in time-to-event data

Arthur Allignol,  Jan Beyersmann,  Claudia Schmoor, 
  • Pages: 297-305
  • First Published: 01 March 2016

Analysing adverse events by time-to-event models: the CLEOPATRA study

Tanja Proctor,  Martin Schumacher, 
  • Pages: 306-314
  • First Published: 16 June 2016

Safety data from randomized controlled trials: applying models for recurrent events

Johannes Hengelbrock,  Johanna Gillhaus,  Sebastian Kloss,  Friedhelm Leverkus, 
  • Pages: 315-323
  • First Published: 12 June 2016

Literature Review

Structured Benefit–risk assessment: a review of key publications and initiatives on frameworks and methodologies

Shahrul Mt-Isa,  Mario Ouwens,  Veronique Robert,  Martin Gebel,  Alexander Schacht,  Ian Hirsch, 
  • Pages: 324-332
  • First Published: 15 May 2015

Main Papers

Open Access

An optimal stratified Simon two-stage design

Deepak Parashar,  Jack Bowden,  Colin Starr,  Lorenz Wernisch,  Adrian Mander, 
  • Pages: 333-340
  • First Published: 02 March 2016

A Bayesian hierarchical surrogate outcome model for multiple sclerosis

Luca Pozzi,  Heinz Schmidli,  David I. Ohlssen, 
  • Pages: 341-348
  • First Published: 07 April 2016

Testing treatment effect in schizophrenia clinical trials with heavy patient dropout using latent class growth mixture models

Fanhui Kong,  Yeh-Fong Chen, 
  • Pages: 349-361
  • First Published: 12 May 2016
Open Access

Why are two mistakes not worse than one? A proposal for controlling the expected number of false claims

Thomas Jaki,  Alice Parry, 
  • Pages: 362-367
  • First Published: 20 April 2016

A modified varying-stage adaptive phase II/III clinical trial design

Gaohong Dong,  Marc Vandemeulebroecke, 
  • Pages: 368-378
  • First Published: 05 June 2016

Erratum

Free Access

The analysis of incontinence episodes and other count data in patients with overactive bladder by Poisson and negative binomial regression

R. Martina,  R. Kay,  R. van Maanen,  A. Ridder, 
  • Pages: 379
  • First Published: 11 May 2016