Presentations
Clinical Trial Design and Implementation Innovations

2008

ExL Pharma's 3rd Data Monitoring Committees Conference - Session 1
ExL Pharma's 3rd Data Monitoring Committees Conference - Session 2
ExL Pharma's 3rd Data Monitoring Committees Conference - Session 3
February 25, 26 2008 - Philadelphia, PA
Evaluating trial safety and efficacy through independent examination of interim clinical data. Cytel founder and president Cyrus Mehta presented three sessions.

Adaptive Trials: Opportunities and Issues
Presented during a workshop at CBI's Adaptive Logistics Conference
January 24, 25 2008 - Philadelphia, PA
Workshop organized and presented by Ranganath Nayak, CEO, Cytel Inc.

Drug Supply for Adaptive Trials
Presented by invitation at CBI's Adaptive Logistics Conference
January 24, 25 2008 - Philadelphia, PA
Nitin Patel, Co-Founder, Chairman and CTO, Cytel Inc.

Design of Adaptive Trials with Population Enrichment
Presented by invitation at SMI’s Adaptive Trials in Clinical Development
February 7, 2008 - London, UK
Cyrus R. Mehta, President, Cytel Inc.

2007

Recent Advances in Survival Studies Design
Cytel Webinar featuring EastSurv survival trials design option for East
October 10, 2007 - online
Yannis Jemiai, Senior Statisticians and East Product Mgr., Cytel Inc.

Sample Size Re-Estimation and Seamless Phase 2/3 Trials: Case Studies
Invited talk for "Adaptive Trial Designs" conference
September 10-11, 2007 - Philadelphia, PA
Misha Salganik and Yannis Jemiai, Senior Statisticians, Cytel Inc.

Exact Confidence Intervals for Group Sequential Adaptive Trials
As presented at invited Joint Statistical Meetings 2007 session
August 1, 2007 - Salt Lake City, UT
Cyrus R. Mehta, President, Cytel Inc.

Benefits and Dangers of a Seamless Phase 2 & 3 Trial
Case study presentation for ExL Pharma's "Adaptive Trial Design Innovations"
July, 2007 - Alexandria, VA
Cyrus R. Mehta, President, Cytel Inc.

Four Adaptive Trial Case Studies
As presented during the FDA News online seminar "Adaptive Trial Design Case Studies"
Feb 2, 2007
Cyrus R. Mehta, President, Cytel Inc.

Bayesian Adaptive Designs for Phase 2a Proof-of-Concept Clinical Trials
A featured talk at CBI's "Adaptive Dose Finding Trials Conference"
Feb 26, 2007 - Philadelphia, PA
Nitin Patel, Chairman and CTO, Cytel Inc.
James Bolognese, Inna Perevozskaya, Merck Research Labs

Adaptive Trial Design Address to the Mass Biotech Council Clinical Trials Committee
Invited talk delivered at the Mass Biotech Council headquarters
April 13, 2007 - Cambridge, MA
Cyrus R. Mehta, President, Cytel Inc.

2006

Strategies for Implementing Flexible Clinical Trials
2006 FDA/Industry Statistics Workshop talk
Dec 13, 2006 - Bethesda, MD
Jerald Schindler, Cytel Inc.

Case Study of a Flexible Adaptive Design
PhRMA Adaptive Design Workshop talk
Dec 13, 2006 - Bethesda, MD
Cyrus Mehta, Cytel Inc.

Confidence Intervals and Point Estimates after an Adaptive Group Sequential Test
As presented to the PhRMA Adaptive Trial Working Group
May 17, 2006
Cyrus R. Mehta, President, Cytel Inc.

Introduction to Flexible, Adaptive Designs
An invited talk for the Henry Stewart Talks DVD: "The Design and Analysis of Randomized Clinical Trials"
May 17, 2006
Cyrus R. Mehta, President, Cytel Inc.

2005

Implementing Adaptive Trials: Software and Process to Accelerate the Use of Adaptive Trials Across the Drug Development Portfolio
IBC's Clinical Trial Innovation invited talk on adaptive trials
Nov 8, 2005
Jerald Schindler, Cytel Inc.

Flexible Design with Maximum Information and Adaptive Clinical Trials PDF 133KB
Cyrus R. Mehta
Midwest Biopharmaceutical Statistics Workshop
May 24, 2005

Adaptive Clinical Trials: Extending the Group Sequential Methodology PDF 522KB
Cyrus R. Mehta
26th Annual Meeting of the Society for Clinical Trials
May 21, 2005

Sample Size, Significance Tests and Other Design Considerations for Clinical Trials PDF 311KB
Cyrus R. Mehta
Tufts CSDD Postgraduate Course
February 8, 2005

2004

Design and Interim Monitoring of Flexible Clinical Trials PDF 946KB
Cyrus R. Mehta
BASS XI- Eleventh Annual BioPharmaceutical Applied Statistics Symposium
November 1-5, 2004

Understanding, Applying and Not Misusing the Mathematical and Statistical Techniques Used in Clinical Trials
Cyrus R. Mehta
October 27-28, 2004

Combining Phases II and III into One Trial: An Anti-Depression Case Study PDF 125KB
Cyrus R. Mehta, Ph.D. and Jerald S. Schindler
DIA Annual Meeting
June 15, 2004

Clustering Models to Improve Forecasts in Retail Merchandising PDF 475KB
Nitin R. Patel, Ph.D.
INFORMS 2004
April 25, 2004

Power Comparisons of Adaptive Two-Stage Designs PDF 160KB
Cyrus R. Mehta, Anastasios Tsiatis, Yuliya Lokhnygina
ENAR
March 28, 2004

Flexible Clinical Trial Design PDF 583 KB
Cyrus R. Mehta, Ph.D.
Adaptive Design in Clinical Trials: Statistical Methodologies and Applications
March 4, 2004

Design and Interim Monitoring of Flexible Clinical Trials PDF 281KB
Cyrus R. Mehta, Ph.D.
Massachusetts Biotechnology Conference
March 9, 2004

2003

Conditional Inference in Logistic Regression PDF 385KB
Nitin R. Patel, Ph.D., Cytel Inc. & Sloan School of Management, MIT
The Adaptive Designs for Clinical Trials
Professor L.J. Wei, Dept. of Biostatistics, Harvard University
Massachusetts Biotechnology Council, November 7, 2003

Exact Logistic Regression: Theory, Computation and Examples PDF 164KB
Cyrus R. Mehta, Ph.D.
International Conference on Statistics, Combinatorics and Related Areas, October 3-5, 2003

Role of Interim Monitoring for Flexible Trial Design PDF 274KB
Cyrus R. Mehta, Ph.D.
Applying Statistical Concepts to Clinical Investigation: A Primer for Non-Statisticians, September 29-30, 2003

Interim Monitoring of Clinical Trials for Efficacy, Safety and Futility PDF 658KB
Cyrus R. Mehta, Ph.D.
Exact Target Estimation in Logistic Regression PDF 360KB
Data Mining in Excel Using XLMiner™ PDF 493KB
Nitin R. Patel, Ph.D.
2003 Joint Statistical Meeting, August 3-7, 2003

Flexible Design and Interim Monitoring of Clinical Trials Abstract PDF - 68KB
Cyrus R. Mehta, Ph.D.
MBC and Massachusetts ASA Workshop, July 30, 2003

Comparing Adaptive and Classical Group Sequential Methods for Clinical Design PDF 205KB
Cyrus R. Mehta, Ph.D.
ISCB/SCT 3rd Joint Meeting, July 20-24, 2003

Flexible Design and Monitoring of Clinical Trials
Cyrus R. Mehta, Ph.D.
The Philadelphia Chapter of the ASA's Summer Short Course, July 8, 2003

A Flexible Approach to Clinical Trials - Adaptive and Sequential Designs in Practice PDF 293KB
Cyrus R. Mehta, Ph.D.
DIA 39th Annual Meeting, June 15-19, 2003

Live Demonstration of East v3.0 PDF 392KB
Webcast, April 24th & April 29th, 2003

Mid-Course Correction to Group Sequential Clinical Trials PDF 199KB
Cyrus R. Mehta Ph.D.
ENAR 2003 Spring Meeting, March 30 - April 2, 2003

StatXact 5 for Nonparametric Inference PDF 967KB
Anthony J. Babinec
ASA Chicago Chapter, January, 2003

Group Sequential Design and Analysis
January 14-15, 2003