• Issue

    Pharmaceutical Statistics: Volume 22, Issue 3

    415-584
    May/June 2023
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ISSUE INFORMATION

Free Access

Issue Information

  • Pages: 415-417
  • First Published: 14 May 2023

MAIN PAPERS

Open Access

Parametric and nonparametric methods for confidence intervals and sample size planning for win probability in parallel-group randomized trials with Likert item and Likert scale data

Guangyong Zou,  Lily Zou,  Shi-fang Qiu, 
  • Pages: 418-439
  • First Published: 16 December 2022

Incorporating historical information to improve dose optimization design with toxicity and efficacy endpoints: iBOIN-ET

Yunqi Zhao,  Rachael Liu,  Kentaro Takeda, 
  • Pages: 440-460
  • First Published: 13 December 2022

Statistical considerations for assessing precision of heterogeneous duplicate measurements: An application to pharmaceutical bioanalysis

Jorge Quiroz,  Satrajit Roychoudhury, 
  • Pages: 461-474
  • First Published: 21 December 2022
Open Access

Vaccine clinical trials with dynamic borrowing of historical controls: Two retrospective studies

Andrea Callegaro,  Naveen Karkada,  Emmanuel Aris,  Toufik Zahaf, 
  • Pages: 475-491
  • First Published: 06 January 2023

An improved score-type confidence interval for stratified risk differences involving rare events

Yetao Hu,  Kaifeng Lu,  Lei Xie,  Wei Zhu, 
  • Pages: 492-507
  • First Published: 30 December 2022
Open Access

Natural cubic splines for the analysis of Alzheimer's clinical trials

Michael C. Donohue,  Oliver Langford,  Philip S. Insel,  Christopher H. van Dyck,  Ronald C. Petersen,  Suzanne Craft,  Gopalan Sethuraman,  Rema Raman,  Paul S. Aisen,  For the Alzheimer's Disease Neuroimaging Initiative , 
  • Pages: 508-519
  • First Published: 10 January 2023

A fiducial approach for testing the non-inferiority of proportion difference in matched-pairs design

Chao Chen,  Siyang Ye,  Jiahao Xu,  Kai Wan,  Yanting Chen, 
  • Pages: 520-530
  • First Published: 05 January 2023

Bayesian hierarchical models for adaptive basket trial designs

Chian Chen,  Chin-Fu Hsiao, 
  • Pages: 531-546
  • First Published: 10 January 2023

Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score-integrated composite likelihood approach

Changhong Song,  Heng Li,  Wei-Chen Chen,  Nelson Lu,  Ram Tiwari,  Chenguang Wang,  Yunling Xu,  Lilly Q. Yue, 
  • Pages: 547-569
  • First Published: 05 March 2023

CASE STUDY

Open Access

Re-randomization tests as sensitivity analyses to confirm immunological noninferiority of an investigational vaccine: Case study

Luca Grassano,  Giulia Ranzato,  Michele Pellegrini,  Marco Costantini, 
  • Pages: 570-576
  • First Published: 27 January 2023

SHORT COMMUNICATION

Open Access

Improving early phase oncology clinical trial design: An opportunity for statisticians

Alan Phillips,  Shalini Mondal, 
  • Pages: 577-580
  • First Published: 27 December 2022

VIEWPOINT

Just say no to data listings!

Mercidita Navarro,  Nancy Brucken,  Aiming Yang,  Greg Ball, 
  • Pages: 581-584
  • First Published: 03 January 2023