Pharmaceutical Statistics

Table of Contents

Volume 18 Issue 2 (March 2019)

123-273

Issue Information

Issue Information

  • Author:
  • Pub Online: Mar 21, 2019
  • DOI: 10.1002/pst.1882 (p 123-125)

MAIN PAPERS

Subgroup analysis and interpretation for phase 3 confirmatory trials: White paper of the EFSPI/PSI working group on subgroup analysis

  • Author: Aaron Dane, Amy Spencer, Gerd Rosenkranz, Ilya Lipkovich, Tom Parke
  • Pub Online: Dec 27, 2018
  • DOI: 10.1002/pst.1919 (p 126-139)

Commentaries

MAIN PAPERS

Treatment effect quantification for time‐to‐event endpoints–Estimands, analysis strategies, and beyond

  • Author: Kaspar Rufibach
  • Pub Online: Nov 26, 2018
  • DOI: 10.1002/pst.1917 (p 145-165)

On estimands and the analysis of adverse events in the presence of varying follow‐up times within the benefit assessment of therapies

  • Author: Steffen Unkel, Marjan Amiri, Norbert Benda, Jan Beyersmann, Dietrich Knoerzer, Katrin Kupas, Frank Langer, Friedhelm Leverkus, Anja Loos, Claudia Ose, Tanja Proctor, Claudia Schmoor, Carsten Schwenke, Guido Skipka, Kristina Unnebrink, Florian Voss, Tim Friede
  • Pub Online: Nov 20, 2018
  • DOI: 10.1002/pst.1915 (p 166-183)

A simple test for the treatment effect in clinical trials with a sequential parallel comparison design and negative binomial outcomes

  • Author: Gosuke Homma, Takashi Daimon
  • Pub Online: Nov 08, 2018
  • DOI: 10.1002/pst.1913 (p 184-197)

Bayesian sample size determination for phase IIA clinical trials using historical data and semi‐parametric prior's elicitation

  • Author: Paola Berchialla, Sarah Zohar, Ileana Baldi
  • Pub Online: Nov 15, 2018
  • DOI: 10.1002/pst.1914 (p 198-211)

Phase II trial design with growth modulation index as the primary endpoint

  • Author: Jianrong Wu, Li Chen, Jing Wei, Heidi Weiss, Rachel W. Miller, John L. Villano
  • Pub Online: Nov 20, 2018
  • DOI: 10.1002/pst.1916 (p 212-222)

Propensity‐score‐based priors for Bayesian augmented control design

  • Author: Junjing Lin, Margaret Gamalo‐Siebers, Ram Tiwari
  • Pub Online: Dec 09, 2018
  • DOI: 10.1002/pst.1918 (p 223-238)

On weighted composite scores for early Alzheimer's trials

  • Author: Kun Jin, Briana Cameron, Billy Dunn
  • Pub Online: Dec 18, 2018
  • DOI: 10.1002/pst.1920 (p 239-247)

Study design aspects and inter‐subject variability in longitudinal clinical phase II dose‐finding trials

  • Author: Lieven Nils Kennes, Gisela Volkers, Georg Kralidis
  • Pub Online: Jan 08, 2019
  • DOI: 10.1002/pst.1921 (p 248-259)

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