+
|
Data Monitoring Committee Reports: Telling the Dataâs Story
|
2024
|
Lijuan Zeng
Toshimitsu Hamasaki
Scott Evans
|
+
|
Longitudinal benefit:risk analysis through the desirability of outcome ranking (DOOR) with application to ACTT-1 Trial
|
2024
|
Shiyu Shu
Guoqing Diao
Toshimitsu Hamasaki
Scott Evans
|
+
PDF
Chat
|
Exploration of a Potential DOOR Endpoint for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs
|
2024
|
Tori Kinamon
Ursula Waack
Mark Needles
Daniel B. Rubin
Deborah Collyar
Sarah B. Doernberg
Scott Evans
Toshimitsu Hamasaki
Thomas L Holland
Jessica HowardâAnderson
|
+
|
Design of Clinical Trials with the Desirability of Outcome Ranking Methodology
|
2024
|
Toshimitsu Hamasaki
Yijie He
Q Wu
Scott Evans
|
+
|
Benefit:Risk Assessments During Clinical Trials: A Prediction Approach Using the Desirability of Outcome Ranking (DOOR)
|
2024
|
Lijuan Zeng
Toshimitsu Hamasaki
Lizhao Ge
Yijie He
Scott Evans
|
+
|
<i>Statistics in Biopharmaceutical Research</i> Best Papers Award 2023
|
2023
|
Toshimitsu Hamasaki
Freda Cooner
|
+
|
Generalized fiducial inference for the restricted mean survival time
|
2023
|
Ionut Bebu
Guoqing Diao
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Editorâs Note: Special Section on a Collection of Articles on Opportunities and Challenges in Utilizing Real-World Data for Clinical Trials and Medical Product Development
|
2023
|
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Weighing evidence: robustness vs quantity
|
2022
|
Scott Evans
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Statistics in Medicine
|
2022
|
Weixiao Dai
Toshimitsu Hamasaki
|
+
|
[Multiple Endpoints in Oncology Clinical Trials].
|
2022
|
Toshimitsu Hamasaki
Frank Bretz
|
+
|
Multiple Endpoints in Multiregional Clinical Trials
|
2021
|
Toshimitsu Hamasaki
YuhâJenn Wu
ChinâFu Hsiao
|
+
|
Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics
|
2021
|
Freda Cooner
Toshimitsu Hamasaki
Frank Bretz
Gene Pennello
Martin Posch
|
+
PDF
Chat
|
<i>Statistics in Biopharmaceutical Research</i> Best Papers Award
|
2021
|
Toshimitsu Hamasaki
Frank Bretz
|
+
PDF
Chat
|
Special Issue for Selected Articles From the ISBS2019: Statistical Innovation and Contribution in the Era of Precision Healthcare
|
2021
|
Toshimitsu Hamasaki
Satoshi Morita
Jie Chen
|
+
PDF
Chat
|
Editorial: Roles of Hypothesis Testing, <i>p</i>-Values and Decision Making in Biopharmaceutical Research
|
2021
|
Toshimitsu Hamasaki
Frank Bretz
Lisa M. LaVange
Peter MĂŒller
Gene Pennello
JosĂ© CirıÌaco Pinheiro
|
+
|
On selecting the critical boundary functions in group-sequential trials with two time-to-event outcomes
|
2020
|
Toshimitsu Hamasaki
Hung Hung
ChinâFu Hsiao
Scott Evans
|
+
PDF
Chat
|
Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic
|
2020
|
Toshimitsu Hamasaki
Frank Bretz
Freda Cooner
Lisa M. LaVange
Martin Posch
|
+
|
Sequential Multiple Assignment Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART COMPASS): Design Considerations
|
2020
|
Xiaoyan Yin
Toshimitsu Hamasaki
Scott Evans
|
+
PDF
Chat
|
The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
|
2020
|
Munyaradzi Dimairo
Philip Pallmann
James Wason
Susan Todd
Thomas Jaki
Steven A. Julious
Adrian Mander
Christopher J. Weir
Franz Koenig
Marc K. Walton
|
+
PDF
Chat
|
The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
|
2020
|
Munyaradzi Dimairo
Philip Pallmann
James Wason
Susan Todd
Thomas Jaki
Steven A. Julious
Adrian Mander
Christopher J. Weir
Franz Koenig
Marc K. Walton
|
+
|
Sequential Multiple Assignment Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART COMPASS): Design Considerations
|
2020
|
X. Y. Yin
Toshimitsu Hamasaki
Scott Evans
|
+
|
Analysis of ordered composite endpoints
|
2019
|
Dean Follmann
Michael P. Fay
Toshimitsu Hamasaki
Scott Evans
|
+
PDF
Chat
|
Interim Monitoring for Futility in Clinical Trials With Two Co-Primary Endpoints Using Prediction
|
2019
|
Koko Asakura
Scott Evans
Toshimitsu Hamasaki
|
+
PDF
Chat
|
The Adaptive designs CONSORT Extension (ACE) Statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
|
2019
|
Munyaradzi Dimairo
Philip Pallmann
James Wason
Susan Todd
Thomas Jaki
Steven A. Julious
Adrian Mander
Christopher J. Weir
Franz Koenig
Marc K. Walton
|
+
|
Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes
|
2019
|
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
Susan Halabi
|
+
|
Interim Monitoring for Futility in Clinical Trials With Two Co-Primary Endpoints Using Prediction
|
2019
|
Koko Asakura
Scott Evans
Toshimitsu Hamasaki
|
+
|
Interim Monitoring for Futility in Clinical Trials with Two Co-primary Endpoints Using Prediction
|
2019
|
Koko Asakura
Scott Evans
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS)
|
2019
|
Evans S.R.
Dean Follmann
Liu Y
Thomas L Holland
Doernberg S.B.
Nadine Rouphael
Toshimitsu Hamasaki
Yunyun Jiang
Lok J.
Tran T.T.T.
|
+
PDF
Chat
|
Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design
|
2018
|
Munyaradzi Dimairo
Elizabeth Coates
Philip Pallmann
Susan Todd
Steven A. Julious
Thomas Jaki
James Wason
Adrian Mander
Christopher J. Weir
Franz Koenig
|
+
PDF
Chat
|
Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS)
|
2018
|
Scott Evans
Dean Follmann
Ying Liu
Thomas L Holland
Sarah B. Doernberg
Nadine Rouphael
Toshimitsu Hamasaki
Yunyun Jiang
Judith J. Lok
Thuy Tien T. Tran
|
+
PDF
Chat
|
Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review
|
2017
|
Toshimitsu Hamasaki
Scott Evans
Koko Asakura
|
+
PDF
Chat
|
Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints
|
2017
|
Wong-Shian Huang
H. M. James Hung
Toshimitsu Hamasaki
ChinâFu Hsiao
|
+
PDF
Chat
|
Sizing clinical trials when comparing bivariate timeâtoâevent outcomes
|
2017
|
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
Takashi Sozu
|
+
PDF
Chat
|
Interim evaluation of efficacy or futility in groupâsequential trials with multiple coâprimary endpoints
|
2016
|
Koko Asakura
Toshimitsu Hamasaki
Scott Evans
|
+
PDF
Chat
|
Corrigendum: A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints (10.1093/biostatistics/kxs057)
|
2016
|
Tomoyuki Sugimoto
Takashi Sozu
Toshimitsu Hamasaki
Scott Evans
|
+
PDF
Chat
|
Group-sequential three-arm noninferiority clinical trial designs
|
2016
|
Toshimitsu Ochiai
Toshimitsu Hamasaki
Scott Evans
Koko Asakura
Yuko Ohno
|
+
|
Interim Evaluation of Efficacy in Clinical Trials with Two Primary Endpoints
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Sample Size Recalculation in Clinical Trials with Two Co-primary Endpoints
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Group-Sequential Three-Arm Non-inferiority Clinical Trials
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Interim Evaluation of Efficacy or Futility in Clinical Trials with Two Co-primary Endpoints
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Interim Evaluation of Efficacy in Clinical Trials with Two Co-primary Endpoints
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Group-Sequential Clinical Trials with Multiple Co-Objectives
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Introduction
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Future Developments
|
2016
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Toshimitsu Ochiai
|
+
|
Reducing unnecessary measurements in clinical trials with multiple primary endpoints
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Sample Size Considerations in Clinical Trials When Comparing Two Interventions Using Multiple Co-Primary Binary Relative Risk Contrasts
|
2015
|
Yukio Ando
Toshimitsu Hamasaki
Scott Evans
Koko Asakura
Tomoyuki Sugimoto
Takashi Sozu
Yuko Ohno
|
+
PDF
Chat
|
Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes
|
2015
|
Toshimitsu Hamasaki
Koko Asakura
Scott Evans
Tomoyuki Sugimoto
Takashi Sozu
|
+
|
Group-Sequential Designs When Considering Two Binary Outcomes as Co-Primary Endpoints
|
2015
|
Koko Asakura
Toshimitsu Hamasaki
Scott Evans
Tomoyuki Sugimoto
Takashi Sozu
|
+
|
Sample Size Determination in Clinical Trials with Multiple Endpoints
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
|
+
|
Convenient Sample Size Formula
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
|
+
|
Binary Co-primary Endpoints
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
|
+
|
Continuous Co-primary Endpoints
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
|
+
PDF
Chat
|
Two-sample tests for comparing proportions
|
2015
|
Koko Asakura
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Multiple comparisons: comparing more than two treatments
|
2015
|
Koko Asakura
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Two-sample tests for comparing means
|
2015
|
Koko Asakura
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Analysis of survival data
|
2015
|
Koko Asakura
Toshimitsu Hamasaki
|
+
|
Introduction
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
|
+
|
Continuous Primary Endpoints
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
|
+
|
Further Developments
|
2015
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Scott Evans
|
+
|
Design Challenges for Heart Failure Prevention Clinical Trials: Adaptive Design Approach
|
2014
|
Toshimitsu Hamasaki
Atsushi Nakano
Kanae Takahashi
Hideaki Kanzaki
Masanori Asakura
Masafumi Kitakaze
|
+
PDF
Chat
|
Sample size determination in groupâsequential clinical trials with two coâprimary endpoints
|
2014
|
Koko Asakura
Toshimitsu Hamasaki
Tomoyuki Sugimoto
Kenichi Hayashi
Scott Evans
Takashi Sozu
|
+
PDF
Chat
|
Partition testing in confirmatory adaptive designs with structured objectives
|
2013
|
Toshifumi Sugitani
Toshimitsu Hamasaki
Chikuma Hamada
|
+
PDF
Chat
|
A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints
|
2013
|
Tomoyuki Sugimoto
Takashi Sozu
Toshimitsu Hamasaki
Scott Evans
|
+
PDF
Chat
|
Statistical Issues in Clinical Trials with Multiple Primary Endpoints
|
2013
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Sample size determination for clinical trials with coâprimary outcomes: exponential event times
|
2012
|
Toshimitsu Hamasaki
Tomoyuki Sugimoto
Scott Evans
Takashi Sozu
|
+
|
Sample size determination in clinical trials with multiple coâprimary endpoints including mixed continuous and binary variables
|
2012
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
|
+
|
A convenient formula for sample size calculations in clinical trials with multiple coâprimary continuous endpoints
|
2012
|
Tomoyuki Sugimoto
Takashi Sozu
Toshimitsu Hamasaki
|
+
|
Sample Size Determination in Superiority Clinical Trials with Multiple Co-Primary Correlated Endpoints
|
2011
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
|
+
PDF
Chat
|
A simple modification of the Box and Cox transformation to scale stability and invariance
|
2011
|
Toshimitsu Hamasaki
Tomoyuki Sugimoto
Seoyoung C. Kim
|
+
|
A Note on Analysis of Ratio of Two Correlated Normal Variables
|
2011
|
Koko Asakura
Hiroyuki Uesaka
Tomoyuki Sugimoto
Toshimitsu Hamasaki
|
+
|
Sample size determination in clinical trials with multiple coâprimary binary endpoints
|
2010
|
Takashi Sozu
Tomoyuki Sugimoto
Toshimitsu Hamasaki
|
+
|
Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective
|
2010
|
Yukio Ando
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Practical application of cure mixture model for long-term censored survivor data from a withdrawal clinical trial of patients with major depressive disorder
|
2010
|
Ichiro Arano
Tomoyuki Sugimoto
Toshimitsu Hamasaki
Yuko Ohno
|
+
PDF
Chat
|
Box and Cox power-transformation to additivity and homoscedasticity in regression
|
2010
|
Toshimitsu Hamasaki
Tomoyuki Sugimoto
Masashi Goto
|
+
PDF
Chat
|
A COMPARISON OF METHODS FOR PARAMETER ESTIMATION OF THE SHIFTED POWER TRANSFORMATION
|
2007
|
Toshimitsu Hamasaki
Tomoyuki Sugimoto
|
+
PDF
Chat
|
The Role of Randomization in Clinical Trials
|
2007
|
Ichiro Arano
Toshimitsu Hamasaki
Tomoyuki Sugimoto
|
+
|
Box and Cox power-transformation to confined and censored nonnormal responses in regression
|
2006
|
Toshimitsu Hamasaki
Seoyoung C. Kim
|
+
|
Properties of estimators of baseline hazard functions in a semiparametric cure model
|
2006
|
Tomoyuki Sugimoto
Toshimitsu Hamasaki
|
+
PDF
Chat
|
Power-Transformation Model to Additivity in Regression
|
2005
|
Toshimitsu Hamasaki
Masashi Goto
|
+
PDF
Chat
|
ASYMPTOTIC PROPERTIES OF ESTIMATES OF THE POWER-TRANSFORMATION MODEL TO BIVARIATE GROUPED DATA
|
2005
|
Toshimitsu Hamasaki
Masashi Goto
|
+
PDF
Chat
|
DIAGNOSTIC METHODS IN THE APT MODEL FOR ORDERED CATEGORICAL DATA
|
2003
|
Toshimitsu Hamasaki
Masashi Goto
|
+
PDF
Chat
|
SIMULTANEOUS DIAGNOSTIC METHODS FOR THE DOUBLE POWER-NORMAL TRANSFORMATION MODEL
|
2003
|
Masashi Goto
Toshimitsu Hamasaki
|
+
PDF
Chat
|
2. Clinical and Medical Evaluation Process
|
2003
|
Tatsuya Isomura
Toshimitsu Hamasaki
Masashi Goto
|
+
PDF
Chat
|
STATISTICAL INFERENCES OF GROUPED DATA COMBINED WITH UNGROUPED DATA FROM THE POWER-NORMAL DISTRIBUTION
|
2002
|
Toshimitsu Hamasaki
Masashi Goto
|
+
PDF
Chat
|
On Inferences of Parameters in the Bivariate Power-Normal Distribution
|
2002
|
Toshimitsu Hamasaki
Masashi Goto
|
+
|
PRACTICAL ISSUES AND OBSERVATIONS ON THE USE OF FOREIGN CLINICAL DATA IN DRUG DEVELOPMENT
|
2002
|
Masashi Goto
Toshimitsu Hamasaki
|
+
|
Statistical Approaches to Detecting Dose-Response Relationships
|
2000
|
Toshimitsu Hamasaki
Tatsuya Isomura
Mitsumasa Baba
Masashi Goto
|
+
PDF
Chat
|
None
|
1999
|
Toshimitsu Hamasaki
Tatsuya Isomura
Megu Ohtaki
Masashi Goto
|
+
PDF
Chat
|
INFERENCES BASED ON THE GROUPED OBSERVATIONS FROM THE BIVARIATE POWER-NORMAL DISTRIBUTION
|
1998
|
Toshimitsu Hamasaki
Masashi Goto
|
+
PDF
Chat
|
None
|
1998
|
Toshimitsu Hamasaki
Masashi Goto
|
+
|
An Optimal Excitation Method in Multi-Applicator Systems for Forming a Hot Zone Inside the Human Body
|
1986
|
N. Morita
Toshimitsu Hamasaki
Naoya Kumagai
|