Adaptive and Multi-Arm Trial Design and Implementation

2011

Preserving Integrity of DMC and Interim Analyses Trials with ACES® (.pdf)
Webinar Slides link above and Demonstration
December 14, 2011 - Replay Webinar Free
Eric Silva, Enterprise and Hosted Solutions, Cytel Inc.

Designing Multi-Arm Clinical Trials with SiZ® (.pdf)
Webinar Presentation and Demonstration
October 4, 2011 - Replay Webinar Free
Cyrus Mehta, President and Co-Founder, Cytel Inc.

Confidence Intervals and Point Estimates for Adaptive Group Sequential Trials
ASA Joint Statistical Meetings (JSM) Invited Session
August 3, 2011 - Miami, FL
Lingyun Liu, Cytel Inc.

New Software: Design and Simulation of Trials with Multiple Treatment Arms (.pdf)
ASA Joint Statistical Meetings (JSM) Workshop
August 3, 2011 - Miami, FL
Cyrus Mehta, President and Co-Founder, Cytel Inc.

Better Ways to Get the Dose Right with Cytel's Compass Software (.pdf)
ASA Joint Statistical Meetings (JSM) Workshop
August 3, 2011 - Miami, FL
Yannis Jemiai and James Bolognese, Cytel Inc.

Designing Adaptive Programs for Neuropathic Pain and the Product Revenue Implications (.pdf)
Drug Information Association (DIA) Invited Talk
June 22, 2011 - Chicago, IL
Nitin Patel, CTO and Co-Founder, Cytel Inc.

Combining Design and Execution of Adaptive Trials: AML Oncology Case Study (.pdf)
Drug Information Association (DIA) Invited Talk
June 23, 2011 - Chicago, IL
Cyrus Mehta, President and Co-Founder, Cytel Inc.

Implementing Adaptive Designs: Technology to Protect Trial Integrity, Reduce Operational Bias, and Build Regulatory Trust (.pdf)
Drug Information Association (DIA) Invited Talk
June 23, 2011 - Chicago, IL
Eric Silva, Enterprise and Hosted Solutions, Cytel Inc.

Transforming Oncology Development with Adaptive Studies (.pdf)
Webinar Presentation and Exchange with Oncologist Dr. John Grous
April 8, 2011 - Replay Webinar Free
Cyrus Mehta, President and Co-Founder, Cytel Inc.

Adaptive Drug Development Programs for Phases 2 & 3 in Neuropathic Pain
International Symposium on Biopharmaceutical Statistics, Invited Talk
March, 2011 - Berlin
Nitin Patel, CTO, Chairman and Co-Founder, Cytel Inc.

2010

Statistical Design Strategies for De-Risking Oncology Drug Development
Oncology Clinical Trials Conferences
November 10, 2010 - Boston
November 30, 2010 - Munich
Yannis Jemiai, Director of Biostatistics, Cytel Inc.

Bayesian Designs for Medical Device Clinical Trials
Medical Development Group Annual Forum, Invited Talk
November 3, 2010 - Waltham, MA
Nitin Patel, CTO, Chairman and Co-Founder, Cytel Inc.

East® SurvAdapt: Adaptive Sample Size Re-estimation of Confirmatory Time-to-Event Trials (.pdf)
Cytel New Software Demonstration
October 28, 2010 - Replay Webinar Free
Cyrus Mehta, President and Co-Founder, Cytel Inc.

CDISC Clinical Data Migration: Automation and the SDTM
Presented at the 2010 PhUSE Conference
October, 2010 - Berlin
Jim Nigrelli and Ajay Sathe, Cytel Inc.

Designing Adaptive Dose-Finding Trials with Compass®
JSM 2010 Technology Workshop 31
August 4, 2010 - Vancouver
Nitin Patel, CTO, Chairman and Co-Founder, with Yannis Jemiai, Director of Biostatistics, Cytel Inc.

Adaptive Population Re-estimation Trial Design with East®Adapts
JSM 2010 Technology Workshop 24
August 4, 2010 - Vancouver
Cyrus Mehta, President and Co-Founder, Cytel Inc.

Adaptive by Design, The Cost of Goods, and Better Execution of Adaptive Studies
Biorbis Cancer Vaccines Conference
July 28 - 30, 2010 - Cambridge, MA
Judith Quinlan, Vice President Adaptive Trials, Cytel Inc.

Get the Dose Right with Compass®;
Accompanying Slides to Debut Software Demonstration
June 3, 2010 - Online
Yannis Jemiai, Director of Biostatistics, Cytel Inc.

Adaptive and Seamless Designs: Making the Right Decisions
SMi's Adaptive Clinical Conference
February 3, 2010 - London
Yannis Jemiai, Associate Director, Biostatistics, Cytel Inc.
Updated: 20-Feb, Biologics Conference, Baltimore

Testing a Primary and Secondary Endpoint in a Confirmatory Group
ExL Pharma's Multiple Comparisons in Clinical Trials
January 25, 2010 - Rockville, MD
Cyrus R. Mehta, President and Co-Founder, Cytel Inc.

2009

Case Studies: Adaptive and Seamless Designs for Late Stage Oncology Studies
Phacilitate's Oncology and R&D Leaders Forums
November 10, 2009 - Boston
Yannis Jemiai, Director of Biostatistics, Cytel Inc.

Modeling and Simulation for Dose Selection using Adaptive Designs
PhRMA and FDA Meeting Meeting: "Qualitative Approaches for Decision Making"
October 30, 2009 - Bethesda, MD
Nitin Patel, CTO and Co-Founder, Cytel Inc.

Webinar Slides: Introducing SiZ®
A Cytel Webinar Event
October 6 & 8, 2009 - online
Yannis Jemiai, Director of Biostatistics, Cytel Inc.

Adaptive Design: Where Are We Now?
JSM 2009 Annual Meeting of the American Statistical Association
August 4, 2009 - Washington, DC
Cyrus R. Mehta, President and Co-Founder, Cytel Inc.

Introduction to SiZ®: Design, Simulate and Analyze Fixed Sample Size Trials
JSM 2009 Annual Meeting of the American Statistical Association
Aug 5, 2009 - Washington, DC
Yannis Jemiai, Associate Director, Biostatistics, Cytel Inc.

T-Statistic-based Up&Down Dose-Finding Design Competes Favorably v. Bayesian 4-parameter Logistic Design
JSM 2009 Annual Meeting of the American Statistical Association
Aug 3, 2009 - Washington, DC
Jim Bolognese, Cytel Inc., and colleagues from Merck, Wyeth and Millennium

Planning for Success: The Role of Simulations
ExL Pharma Trial Design Innovations Conference
July 14 & 15, 2009 - Washington, DC
Judith Quinlan, Vice President Adaptive Trials, Cytel Inc.

Seamless and Adaptive Designs In Late Stage Oncology Trials
SMi's Clinical Trials in Cancer Conference
July 1 & 2, 2009 - London
Yannis Jemiai, Associate Director, Biostatistics, Cytel Inc.

Designing Adaptive Trials with the New EastAdapt
A Cytel Webinar Event Replay Webinar 24/7
June 16 & 19, 2009 - online
Cyrus R. Mehta, President and Co-Founder, Cytel Inc.

Planning for Success: The Balance Between Design AND Implementation
Presented at the BIO 2009 Convention's Adaptive Trials Session
May 20, 2009 - Atlanta, GA
Judith Quinlan, Vice President Adaptive Trials, Cytel Inc.

The New Role of Drug Supply Planning in Adaptive Trials
Presented at the Clinical Supply Forecasting Conference
April 7, 2009 - Philadelphia, PA
Nitin Patel, CTO and Co-Founder, Cytel Inc.

Planning for Success: The Cost of Goods and the Importance of Getting the Dose Right
Presented at the Q1 Biologics Trials Conference
March 30, 2009 - Baltimore, MD
Judith Quinlan, Vice President Adaptive Trials, Cytel Inc.

2008

Adaptive Group Sequential Trials with Multiple Endpoints
Invited talk before the FDA/ASA Biostatistical Industry Workshop
September 15, 2008 - Washington, DC
Cyrus R. Mehta, President and Co-Founder, Cytel Inc.

Adaptive Group Sequential Trials with Population Enrichment
Presented at the ASA's Joint Statistical 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 practices 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 American 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.

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.

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.