P. Gallo

发表

The future of drug development: advancing clinical trial design

C. Mehta, J. Orloff, F. Douglas, 2009, Nature Reviews Drug Discovery.

Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group

M. Krams, J. Pinheiro, P. Gallo, 2006, Journal of biopharmaceutical statistics.

Confidentiality and Trial Integrity Issues for Adaptive Designs

P. Gallo, 2006 .

Alternative Views On Setting Clinical Trial Futility Criteria

P. Gallo, L. Mao, V. Shih, 2014, Journal of biopharmaceutical statistics.

On the Optimal Timing of Futility Interim Analyses

P. Gallo, D. Ohlssen, Dong Xi, 2017 .

CENTER-WEIGHTING ISSUES IN MULTICENTER CLINICAL TRIALS

P. Gallo, 2000, Journal of biopharmaceutical statistics.

Rejoinder

M. Krams, J. Pinheiro, P. Gallo, 2006 .

Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis.

Yoshiaki Uyama, Lihui Zhao, Paul Gallo, 2014, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job

S. Ellenberg, F. Rockhold, P. Gallo, 2019, Annals of Internal Medicine.

An adaptive strategy for assessing regional consistency in multiregional clinical trials

Hui Quan, Paul Gallo, Joshua Chen, 2012, Clinical trials.

Viewpoints on the FDA Draft Adaptive Designs Guidance from the PhRMA Working Group

M. Krams, J. Pinheiro, P. Gallo, 2010, Journal of biopharmaceutical statistics.

Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity.

Song Yang, P. Gallo, H. Quan, 2018, Therapeutic innovation & regulatory science.

Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 2: Monitoring, Reporting, and Interpretation

P. Gallo, H. Quan, Gang Li, 2011 .

Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 1: Design Considerations

P. Gallo, H. Quan, Gang Li, 2011 .

Inspiratory flow rates and volumes with the Aerolizer dry powder inhaler in asthmatic children and adults

G. D. Cioppa, P. Gallo, E. Bronsky, 2004, Current medical research and opinion.

The changing landscape of data monitoring committees—Perspectives from regulators, members, and sponsors

Jonathan H Seltzer, G. Molenberghs, P. Gallo, 2018, Biometrical journal. Biometrische Zeitschrift.

A Note on Missing Data in Noninferiority Trials

P. Gallo, Christy Chuang-Steiny, 2009 .

A proof-of-concept-to-confirmatory multiple adaptation design in the development of an anti-viral treatment

P. Gallo, G. Su, Xiaoyin F Fan, 2018, Statistical methods in medical research.

A Review of: “Data and Safety Monitoring Committees in Clinical Trials, by J. Herson”

P. Gallo, 2009 .

Adaptive Dose-Response Studies

Paul Gallo, Brenda Gaydos, Michael Krams, 2006 .

Adaptive designs: The Swiss Army knife among clinical trial designs?

Frank Bretz, Willi Maurer, Paul Gallo, 2017, Clinical trials.

Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology

Frank Bretz, Martin Posch, Michael Branson, 2009, Statistics in medicine.

Poisson regression analysis in clinical research.

F. Kianifard, P. Gallo, 1995, Journal of biopharmaceutical statistics.

Challenges in Implementing Futility Schemes, with Reference to Aducanumab

P. Gallo, Satrajit Roychoudhury, 2023, Therapeutic Innovation & Regulatory Science.

A Practical Guide to Data Monitoring Committees in Adaptive Trials

Christy Chuang-Stein, Paul Gallo, Zoran Antonijevic, 2014, Therapeutic innovation & regulatory science.

Addressing Challenges and Opportunities of “Less Well-Understood” Adaptive Designs

Qi Jiang, Eva Miller, Paul Gallo, 2017, Therapeutic innovation & regulatory science.

Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

Christy Chuang-Stein, Vladimir Dragalin, Paul Gallo, 2013, Therapeutic innovation & regulatory science.

Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendations. White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies

Frank Bretz, Joshua R. Smith, Chyi-Hung Hsu, 2010 .

Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development

Donald A. Berry, José Pinheiro, Christy Chuang-Stein, 2009 .

Sample Size Reestimation: A Review and Recommendations

Paul Gallo, Keaven Anderson, Christy Chuang-Stein, 2006 .

Adaptive Seamless Phase II/III Designs—Background, Operational Aspects, and Examples

Jeff Maca, Suman Bhattacharya, Michael Krams, 2006 .

Data Monitoring in Adaptive Dose-Ranging Trials

Frank Bretz, Paul Gallo, Michael Krams, 2010 .

Challenges in Implementing Adaptive Designs: Comments on the Viewpoints Expressed by Regulatory Statisticians

W. Maurer, P. Gallo, 2006, Biometrical journal. Biometrische Zeitschrift.

Simultaneous inference on treatment effects in survival studies with factorial designs

Dan-Yu Lin, Paul Gallo, David Couper, 2016, Biometrics.

Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity

Song Yang, P. Gallo, H. Quan, 2020, Therapeutic Innovation & Regulatory Science.

Graphical assessment of consistency in treatment effect among countries in multi-regional clinical trials

Naitee Ting, P. Gallo, H. Quan, 2013, Clinical trials.

An additive boundary for group sequential designs with connection to conditional error

Paul Gallo, Dong Xi, P. Gallo, 2019, Statistics in medicine.

DIA’s Adaptive Design Scientific Working Group (ADSWG): Best Practices Case Studies for “Less Well-understood” Adaptive Designs

Qi Jiang, Eva Miller, Paul Gallo, 2017, Therapeutic innovation & regulatory science.

Adaptive Clinical Trials: Overview of Phase III Designs and Challenges

Vladimir Dragalin, Paul Gallo, Jeff Maca, 2014, Therapeutic innovation & regulatory science.

Operational challenges in adaptive design implementation

Paul Gallo, P. Gallo, 2006, Pharmaceutical statistics.

What should be the role of homogeneity testing in adaptive trials?

Christy Chuang-Stein, Paul Gallo, P. Gallo, 2009, Pharmaceutical statistics.

Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

Frank Bretz, Janice Branson, Paul Gallo, 2020, Statistics in biopharmaceutical research.

Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials

Hui Quan, Gang Li, Paul Gallo, 2010 .

The Limiting Distribution of Least Squares in an Errors-in-Variables Regression Model

Raymond J. Carroll, Paul P. Gallo, Leon Jay Gleser, 1987 .

Comparison of Least Squares and Errors-in-Variables Regression, with Special Reference to Randomized Analysis of Covariance

Raymond J. Carroll, Paul P. Gallo, Leon Jay Gleser, 1985 .

Discussion of “Some Controversial Multiple Testing Problems in Regulatory Applications” by H. M. J. Hung and S.-J. Wang

Frank Bretz, Willi Maurer, Paul Gallo, 2009 .

Good Practices for Adaptive Clinical Trials

Paul Gallo, P. Gallo, 2010 .

RECONSIDERING SOME ASPECTS OF THE TWO-TRIALS PARADIGM

J Maca, P Gallo, M Branson, 2002, Journal of biopharmaceutical statistics.

PhRMA Working Group on Adaptive Designs: Introduction to the Full White Paper

Paul Gallo, Michael Krams, M. Krams, 2006 .

Considerations for Interim Analyses in Adaptive Trials, and Perspectives on the Use of DMCs

David L. DeMets, Lisa M. LaVange, Paul Gallo, 2014 .