Clinical Trial Design and Implementation Innovations

Adaptive Group Sequential Trials with Population Enrichment
Presented at the ASA's Joint Statitical Meetings
August 3 2008 - Denver, CO
Cyrus R. Mehta, President and Co-Founder, Cytel Inc.

Making Bayesian Statistics Work in Your Clinical Trial
Cytel Webinar slides on Bayesian techniques and trial design applications
July 8, 2008 - online
Jeff Palmer, Senior Statistician, Cytel Inc.

Sneak Preview: What's New in East®
Cytel Webinar featuring all new options for East®: EastXact™, ReportWriter™ and EastAdapt™
June 3, 2008 - online
Yannis Jemiai, Senior Statistician and East Product Mgr., Cytel Inc.

Why Biotechs Should be VERY Interested in Adaptive Designs
Invited talk at BIO International Convention 2008
July 17-20, 2008 - San Diego, CA
Presented by Judith Quinlan - Vice President Adaptive Trials, Cytel Inc.

Experience with Adaptive Dose-Ranging Studies in Early Clinical Development
Adaptive dose-ranging studies invited talk at DIA Boston 2008
June 24, 2008 - Boston, MA
Presented by Judith Quinlan - VP Adaptive Trials, Cytel Inc., with thanks to members of the PhRMA Adaptive Design Working Group

PhRMA Adaptive Design Working Group: Adaptive Design Best Practices Illustrated through Case Studies
Adaptive design best practicies presentation on behalf of the PhRMA Adaptive Design Working Group at DIA 2008
June 24, 2008 - Boston, MA
Presented by Judith Quinlan - Vice President Adaptive Trials, Cytel Inc.

Adaptive Clinical Trials : Solving the Challenges
In depth review of the challenges and solutions when implementing adaptive trials
May 26, 2008 - online
Judith Quinlan - VP Adaptive Trials, Cytel Inc., with acknowledgements to PhRMA ADWG members: Mike Krams and Vlad Dragalin (Wyeth); Brenda Gaydos (Lilly)

PhRMA Working Group on Adaptive Trials: Drug Supply for Adaptive Trials
The challenges and recent technologies that address adaptive trial drug supply planning
April 11, 2008
Nitin R Patel - Co-founder, Chairman and CTO, Cytel Inc.

Adaptive Clinical Trials: Experiences of an Industry Consultant
An invited talk for ENAR ASA (Eastern North America Region Amercian Statistical Association)
March 17, 2008 - Atlanta, GA
Cyrus R. Mehta, President and Co-Founder, Cytel Inc.

1. Designs with Sample Size Increase and Population Enrichment
2. Seamless Phase 2/3 Design
3. Efficacy, Safety and Futility Stopping Boundaries
February 25, 26 2008 - Philadelphia, PA
At ExL Pharma's DMC Meeting, Cytel co-founder and president Cyrus Mehta presented three sessions on trial safety and efficacy through evaluation via independent examination of interim clinical data.

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