Publications

Recent Publications & Reports:

The Intention-to-Treat Principle:  How to Assess the True Effect of Choosing a Medical Treatment
Michelle Detry, Roger Lewis, The Journal of the American Medical Association, July 2, 2014

Predicting Clinical Trial Results Based on Announcements of Interim Analyses
Kristine Broglio, David Stivers, and Donald Berry, Trials, March 7, 2014
(related Unknown Hazard Reduction Excel Spreadsheet described in the article)

Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke
John Carroll, Jeffrey Saver, David Thaler, Richard Smalling, Scott Berry, Lee MacDonald, David Marks, and David Tirschwell for the RESPECT Investigators,
The New England Journal of Medicine, March 21, 2013

Combining Risk Difference and Risk Ratio in Noninferiority Trials of Safety
Kristine Broglio, Jason Connor, Scott Berry, Journal of Biopharmaceutical Statistics, January 18, 2013

An Overview of Bayesian Adaptive Clinical Trial Design
Roger Lewis, Barcelona BioMed Conference Presentation, December 17, 2012

Application of Adaptive Design Methodology in Development of a Long-Acting Glucago-Like Peptide-1 Analog (Dulaglutide):  Statistical Design and Simulations
Zachary Skrivanek, Scott Berry, Don Berry, Jenny Chien, Mary Jane Geiger, James Anderson Jr., Brenda Gaydos,
Journal of Diabetes Science and Technology, November 2012

An Adaptive, Dose-Finding, Seamless Phase 2/3 Study of Long-Acting Glucagon-Like Peptide-1 Analog (Dulaglutide):  Trial Design and Baseline Characteristics
Mary Jane Geiger, Zachary Skrivanek, Brenda Gaydos, Jenny Chien, Scott Berry, Don Berry, James Anderson Jr.,
Journal of Diabetes Science and Technology, November 2012 

Multiplicities in the Assessment of Multiple Vitamins:  Is It Too Soon to Tell Men That Vitamins Prevent Cancer?
Peter Bach, Roger Lewis, The Journal of the American Medical Association, November 14, 2012

Clinical Trial Simulation:  The Value of Single Simulated Trials
Scott Berry, Berry Consultants/Tessella Webinar, November 14, 2012

ADAPT-IT:  Adaptive Designs Accelerating Promising Trials into Treatments
Scott Berry, FDA/Industry Presentation, September 14, 2012

Adaptive Clinical Trials:  A Partial Remedy for the Therapeutic Misconception?
William Meurer, Roger Lewis, Donald Berry, The Journal of the American Medical Association, June 13, 2012

Standards for the Design, Conduct, and Evaluation of Adaptive Randomized Clinical Trials
Michelle Detry, Roger Lewis, Kristine Broglio, Jason Connor, Scott Berry, Don Berry,
PCORI Guidance Report, March 15, 2012