John Scott

Generating author description...

All published works

Action	Title	Year	Authors
+ PDF Chat	Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER	2022	Alexei Ionan Jennifer Clark James Travis Anup Amatya John Scott James P. Smith Somesh Chattopadhyay Mary Jo Salerno Mark Rothmann
+	Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation	2022	Alexei Ionan Miya Paterniti Devan V. Mehrotra John Scott Bohdana Ratitch Sylva H. Collins Shanti Gomatam Lei Nie Kaspar Rufibach Frank Bretz
+ PDF Chat	Application of Bayesian methods to accelerate rare disease drug development: scopes and hurdles	2022	Kelley M. Kidwell Satrajit Roychoudhury Barbara Wendelberger John Scott Tara Moroz Shaoming Yin Madhurima Majumder John Zhong Raymond A. Huml Veronica Miller
+	Conditional power in vaccine trials with seasonal variations	2022	Xinyu Tang Lihan Yan John Scott
+	The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date	2021	Dionne Price John Scott
+	Assessing and communicating heterogeneity of treatment effects for patient subpopulations: Panel discussion on considerations in design and analysis	2020	Mark Rothmann William H. Crown Thomas A. Louis Thomas Permutt Stephen J. Ruberg Jodi B Segal John Scott
+	A new framework to address challenges in quantitative benefit-risk assessment for medical products	2020	Bo Fu Xuefeng Li John Scott Weili He
+ 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
+ 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
+ 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
+	Considerations on Endpoint Selection, Weighting Determination, and Uncertainty Evaluation in the Benefit-Risk Assessment of Medical Product	2016	Haijun Ma Qi Jiang Christy Chuang‐Stein Scott Evans Weili He George Quartey John Scott Shihua Wen Ramin B. Arani
+	Addressing prior-data conflict with empirical meta-analytic-predictive priors in clinical studies with historical information	2016	Judy X. Li Wei-Chen Chen John Scott
+	Bayesian adaptive two-stage design for determining person-time in Phase II clinical trials with Poisson data	2016	Austin L. Hand John Scott Phil D. Young James D. Stamey Dean M. Young
+	Comment	2015	John Scott
+	CBER’s Experience With Adaptive Design Clinical Trials	2015	Min Lin Shiowjen Lee Boguang Zhen John Scott Amelia Dale Horne Ghideon Solomon Estelle Russek‐Cohen
+	Association rule mining in the <scp>US Vaccine Adverse Event Reporting System (VAERS</scp>)	2015	Lai Wei John Scott
+	Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.	2014	Taxiarchis Botsis John Scott Ravi Goud Pamela Toman Andrea Sutherland Robert Ball
+ PDF Chat	Simulating adverse event spontaneous reporting systems as preferential attachment networks	2014	Taxiarchis Botsis Ron O. Ball John Scott
+	Bayesian methods for design and analysis of safety trials	2013	Karen Price H. Amy Xia Mani Lakshminarayanan David Madigan David H. Manner John Scott James D. Stamey Laura Thompson
+	Sample Size Estimation in Single-Arm Clinical Trials with Multiple Testing Under Frequentist and Bayesian Approaches	2012	Boris G. Zaslavsky John Scott
+	BayesWeb: A User-Friendly Platform for Exploratory Bayesian Analysis of Safety Signals from Small Clinical Trials	2011	John Scott Austin L. Hand Layla S. Sian
+	Missing Data Issues at the FDA Center for Biologics Evaluation and Research	2011	John Scott Henry H. Hsu
+	Spatio-Temporal Mixed Models for Diffusion Tensor Magnetic Resonance Imaging	2008	John Scott
+ PDF Chat	Use of OSWALD for analyzing longitudinal data with informative dropout	2006	Amy Begley Gong Tang Sati Mazumdar Patricia R. Houck John Scott Benoit H. Mulsant Charles F. Reynolds
+ PDF Chat	Statistical analysis of longitudinal psychiatric data with dropouts	2006	Sati Mazumdar Gong Tang Patricia R. Houck Mary Amanda Dew Amy Begley John Scott Benoit H. Mulsant Charles F. Reynolds

Common Coauthors

Coauthor	Papers Together
Yukio Ando	4
Douglas G. Altman	4
Toshimitsu Hamasaki	4
Christopher J. Weir	4
Susan Todd	4
Philip Pallmann	4
Jon Nicholl	4
Adrian Mander	4
Steven A. Julious	4
Franz Koenig	4
Marc K. Walton	4
James Wason	4
Michael A. Proschan	4
Munyaradzi Dimairo	4
Daniel Hind	4
Katie Biggs	4
Thomas Jaki	4
Elizabeth Coates	4
Amy Begley	2
Benoit H. Mulsant	2
Mark Rothmann	2
Weili He	2
James D. Stamey	2
Taxiarchis Botsis	2
Sati Mazumdar	2
Gong Tang	2
Austin L. Hand	2
Charles F. Reynolds	2
Alexei Ionan	2
Patricia R. Houck	2
Madhurima Majumder	1
Satrajit Roychoudhury	1
Somesh Chattopadhyay	1
Ghideon Solomon	1
Anup Amatya	1
Frank Waldron-Lynch	1
H. Amy Xia	1
Christina Yap	1
Layla S. Sian	1
Bohdana Ratitch	1
Veronica Miller	1
Tom Parke	1
Ravi Goud	1
Jodi B Segal	1
Barbara Wendelberger	1
Yannis Jemiai	1
Boguang Zhen	1
Dean M. Young	1
Olivier Collignon	1
David H. Manner	1

Commonly Cited References

Action	Title	Year	Authors	# of times referenced
+ PDF Chat	Adaptive increase in sample size when interim results are promising: A practical guide with examples	2010	Cyrus R. Mehta Stuart J. Pocock	6
+ PDF Chat	Adaptive design methods in clinical trials – a review	2008	Shein‐Chung Chow Mark Chang	6
+	CBER’s Experience With Adaptive Design Clinical Trials	2015	Min Lin Shiowjen Lee Boguang Zhen John Scott Amelia Dale Horne Ghideon Solomon Estelle Russek‐Cohen	5
+	Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development	2010	Judith Quinlan Brenda Gaydos Jeff Maca Michael Krams	5
+	Adaptive Design: Results of 2012 Survey on Perception and Use	2014	Caroline C. Morgan Susan Huyck Martin Jenkins Li Chen Alun Bedding Christopher S. Coffey Brenda Gaydos J. Kyle Wathen	5
+ PDF Chat	Adaptive trial designs: a review of barriers and opportunities	2012	John A. Kairalla Christopher S. Coffey Mitchell A Thomann Keith E. Muller	5
+	Adaptive Design Practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013	2016	Xiting Yang Laura Thompson J. T. Chu Sherry Liu Hong Lü Jie Zhou Shanti Gomatam Rong Tang Yu Zhao Yunjiang Ge	4
+	The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease	2011	Yili Pritchett Yannis Jemiai Yuchiao Chang Ishir Bhan Rajiv Agarwal Carmine Zoccali Christoph Wanner Donald M. Lloyd‐Jones Jorge B. Cannata‐Andía Bruce Thompson	4
+ PDF Chat	Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project	2016	William J. Meurer Laurie J. Legocki Samkeliso Mawocha Shirley M. Frederiksen Timothy C. Guetterman William G. Barsan Roger Lewis Donald A. Berry Michael D. Fetters	4
+ PDF Chat	Critical concepts in adaptive clinical trials	2018	Jay Park Kristian Thorlund Edward J. Mills	4
+	Evaluation of the extent of adaptation to sample size in clinical trials for cardiovascular and CNS diseases	2018	Sue‐Jane Wang Hua Peng Hsien-Ming James Hung	4
+	A Bayesian adaptive design for clinical trials in rare diseases	2016	S. Faye Williamson Peter Jacko Sofía S. Villar Thomas Jaki	4
+	Adaptive Designs: Terminology and Classification	2006	Vladimir Dragalin	4
+	The advantages and disadvantages of adaptive designs for clinical trials	2004	Péter Bauer Werner Brannath	4
+	Implementing Adaptive Designs: Logistical and Operational Considerations	2006	Judith Quinlan Michael Krams	4
+	Adaptive Clinical Trials	2008	Christopher S. Coffey John A. Kairalla	4
+	Benefit–risk assessment: the use of clinical utility index	2010	Danièle Ouellet	4
+ PDF Chat	Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency	2014	Amelie Elsäßer Jan Regnström Thorsten Vetter Franz Koenig Robert Hemmings Martina Greco Marisa Papaluca‐Amati Martin Posch	4
+	Designed Extension of Studies Based on Conditional Power	1995	Michael A. Proschan Sally Hunsberger	4
+	Estimands in clinical trials – broadening the perspective	2016	Mouna Akacha Frank Bretz Stephen J. Ruberg	4
+ PDF Chat	Guidelines for the Content of Statistical Analysis Plans in Clinical Trials	2017	Carrol Gamble Ashma Krishan Deborah Stocken Steff Lewis Edmund Juszczak Caroline J Doré Paula Williamson Douglas G. Altman Alan Montgomery Pilar Lim	4
+ PDF Chat	Adaptive designs in clinical trials: why use them, and how to run and report them	2018	Philip Pallmann Alun Bedding Babak Choodari‐Oskooei Munyaradzi Dimairo Laura Flight Lisa V. Hampson Jane Holmes Adrian Mander Lang’o Odondi Matthew R. Sydes	4
+	Adaptive designs for pivotal trials: discussion points from the PSI Adaptive Design Expert Group	2006	Alan J. Phillips Oliver N. Keene	4
+ PDF Chat	An Investigation of the Shortcomings of the CONSORT 2010 Statement for the Reporting of Group Sequential Randomised Controlled Trials: A Methodological Systematic Review	2015	Abigail K. Stevely Munyaradzi Dimairo Susan Todd Steven A. Julious J P Nicholl Daniel Hind Cindy Cooper	4
+ PDF Chat	Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop	2012	Christopher S. Coffey Bruce Levin Christina Clark Cate Timmerman Janet Wittes Peter R. Gilbert Sara Harris	4
+	The role of adaptive trial designs in drug development	2017	François Curtin Stéphane Héritier	4
+	Adaptive Designs for Randomized Trials in Public Health	2009	C. Hendricks Brown Rth Ho Booil Jo Getachew Dagne Peter A. Wyman Bengt Muthén Robert D. Gibbons	4
+	Regulations on Adaptive Design Clinical Trials	2014	Yuanxin Rong	4
+	Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group	2006	Paul Gallo Christy Chuang‐Stein Vladimir Dragalin Brenda Gaydos Michael Krams José Cirı́aco Pinheiro	4
+	Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration	2010	Werner Brannath Hans Ulrich Burger Ekkehard Glimm Nigel Stallard Marc Vandemeulebroecke Gernot Wassmer	4
+ PDF Chat	Three steps to writing adaptive study protocols in the early phase clinical development of new medicines	2014	Ulrike Lorch Martin O’Kane Jӧrg Täubel	4
+	Optimal Timing for Interim Analyses in Clinical Trials	2013	Kanae Togo Manabu Iwasaki	4
+	Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development	2009	Brenda Gaydos Keaven M. Anderson Donald A. Berry Nancy Burnham Christy Chuang‐Stein Jennifer Dudinak Parvin Fardipour Paul Gallo Sam Givens Roger Lewis	4
+	The reassessment of trial perspectives from interim data—a critical view	2005	Péter Bauer Franz Koenig	4
+ PDF Chat	Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate	2015	Michiel R. de Boer Wilma Waterlander Lothar D. J. Kuijper Ingrid HM Steenhuis Jos W. R. Twisk	3
+ PDF Chat	Minimizing the Maximum Expected Sample Size in Two-Stage Phase II Clinical Trials with Continuous Outcomes	2012	James Wason Adrian Mander	3
+ PDF Chat	Optimal multistage designs for randomised clinical trials with continuous outcomes	2011	James Wason Adrian Mander Simon G. Thompson	3
+	On Stopping a Randomized Clinical Trial for Futility	2011	Jay Herson Marc Buyse Janet Wittes	3
+	Exact inference for adaptive group sequential designs	2013	Ping Gao Lingyun Liu Cyrus R. Mehta	3
+	Bayesian Two-Stage Biomarker-Based Adaptive Design for Targeted Therapy Development	2014	Xuemin Gu Nan Chen Caimiao Wei Suyu Liu Vassiliki A. Papadimitrakopoulou Roy S. Herbst J. Jack Lee	3
+	I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy	2009	AD Barker C C Sigman Kelloff Gj NM Hylton DA Berry L. Esserman	3
+	Group sequential designs using a family of type I error probability spending functions	1990	Irving K. Hwang Weichung Joe Shih John S. de Cani	3
+ PDF Chat	Group Sequential Tests for Delayed Responses (with discussion)	2012	Lisa V. Hampson Christopher Jennison	3
+	Designing Multi-arm Multi-stage Clinical Studies	2014	Thomas Jaki	3
+	One‐ and two‐stage design proposals for a phase II trial comparing three active treatments with control using an ordered categorical endpoint	2008	John Whitehead Thomas Jaki	3
+	Application of Adaptive Design Methodology in Development of a Long-Acting Glucagon-like Peptide-1 Analog (Dulaglutide): Statistical Design and Simulations	2012	Zachary Skrivanek Scott Berry Donald A. Berry Jenny Y. Chien Mary Jane Geiger James H. Anderson Brenda Gaydos	3
+	Overrunning and underrunning in sequential clinical trials	1992	John Whitehead	3
+	Adaptive Dunnett tests for treatment selection	2007	Franz Koenig Werner Brannath Frank Bretz Martin Posch	3
+	Similarities and Differences of Bayesian Designs and Adaptive Designs for Medical Devices: A Regulatory View	2013	Gregory Campbell	3
+ PDF Chat	No solution yet for combining two independent studies in the presence of heterogeneity	2015	Andrea Gonnermann Theodor Framke Anika Großhennig Armin Koch	3