Institute for Mathematical Sciences                                        Programs & Activities

 

   
 

Online registration form
   


Enquiries

      General


   

Workshop on the Design and Analysis of Clinical Trials
(24 - 28 October 2011)

Organizing Committee · Visitors and Participants · Overview · Activities · Venue

 

 Organizing Committee

 

Chair

 

Co-chairs

 

Members

 

 Visitors and Participants

 

 

 Overview

 

Clinical trials are an essential component in the development and testing of new drugs or interventions. They vary a lot in types and complexity. They may be sequential or non-sequential, cluster or individually randomized, have different number of treatment arms and may or may not require interim analysis. The endpoint can be a single outcome or a joint outcome comprising binary, continuous and time-to-event outcomes. The mathematical complexities for designing and analyzing the trial thus depend on the specific trial. Mathematics has continued to play a crucial role in helping us understand how to deal with these complicated issues, including how to control hypothesis testing error rates, rein in cost and develop optimal rules for interim analysis when applicable.

Few statistical areas have spurred as much practical interest in the last several years as adaptive design and analysis. A main reason is the increased flexibility and potential cost savings that come with adaptive designs. Currently pharmaceutical companies, the Food and Drug Administration, and the Pharmaceutical Manufacturer’s Association have ongoing working groups dealing with how to incorporate adaptive strategies into clinical trials, and European groups have also made major advances in this area, including software development. The research area is abound with open questions and the adaptive strategies developed in this area have applications far beyond clinical trials.

The goal of this program is to bring together statisticians, biostatisticians and experienced trialists together to exchange cutting-edge research ideas and discuss emerging developments in the design and analysis of adaptive clinical trials. There will be 4 days of presentations by leading experts in the field covering vaccine trials, pragmatic and regulatory issues and recent statistical advances in the design and analysis of clinical trials. The target audience for this workshop is thus broad, ranging from experts in clinical trials, researchers from academia, pharmaceutical and related industries, practitioners running clinical trials and graduate students interested to learn recent advances in adaptive techniques in clinical trials.


 Activities


There will be 4 days of presentations by leading experts in the field covering vaccine trials, pragmatic and regulatory issues and recent statistical advances in the design and analysis of clinical trials.

* Our office will be closed on the Wednesday, 26 Oct 2011 - Deepavali, being Singapore public holiday.


Monday, 24 Oct 2011

08:30am - 09:00am

Registration

 

Chair: Weng Kee Wong, University of California at Los Angeles, USA

09:00am - 10:30am

Short course on adaptive methods for clinical trials (Part I) (PDF 1)

Tze Leung Lai, Stanford University, USA

Balasubramanian Narasimhan, Stanford University, USA

10:30am - 11:00am

--- Coffee Break ---

11:00am - 12:00nn

Software lecture with demo (zip)

Tze Leung Lai, Stanford University, USA

Balasubramanian Narasimhan, Stanford University, USA

12:00nn - 02:00pm

--- Lunch ---

 

Chair: Weng Kee Wong, University of California at Los Angeles, USA

02:00pm - 03:30pm

Short course on adaptive methods for clinical trials (Part II) (PDF 2)

Tze Leung Lai, Stanford University, USA

Balasubramanian Narasimhan, Stanford University, USA

03:30pm - 04:00pm

--- Coffee Break ---

04:00pm - 05:00pm

Software lecture with demo (zip)

Tze Leung Lai, Stanford University, USA

Balasubramanian Narasimhan, Stanford University, USA

Tuesday, 25 Oct 2011

08:30am - 08:50am

Registration

08:50am - 09:00am

Opening Remarks

 

Chair: William Rosenberger, George Mason University, USA

09:00am - 10:15am

Group sequential and adaptive clinical trial designs (PDF)

Chris Jennison, University of Bath, UK

10:15am - 10:45am

--- Coffee Break ---

10:45am - 12:00nn

Multiple comparisons for multiple endpoints and multiple doses (PDF)

Ajit C. Tamhane, Northwestern University, USA

12:00nn - 02:00pm

--- Lunch ---

 

Chair: Nancy Flournoy, University of Missouri, USA

02:00pm - 03:15pm

Principles for response-adaptive randomization (PDF)

William Rosenberger, George Mason University, USA

03:15pm - 03:45pm

--- Coffee Break ---

03:45pm - 05:00pm

Clinical trials for personalized medicine: designs and statistical inference (PDF)

Feifang Hu, University of Virginia, USA

Wednesday, 26 Oct 2011

 

Singapore public holiday

Thursday, 27 Oct 2011

08:45am - 09:00am

Registration

 

Chair: Zhiliang Ying, Columbia University, USA

09:00am - 10:15am

Dose-finding experiments in clinical trials (PDF)

Nancy Flournoy, University of Missouri, USA

10:15am - 10:45am

--- Coffee Break ---

10:45am - 12:00nn

Bayesian adaptive designs for early-phase oncology trials (PDF)

Guosheng Yin, The University of Hong Kong, Hong Kong

12:00nn - 02:00pm

--- Lunch ---

 

Chair: Peter Anthony Lachenbruch, Oregon State University, USA

02:00pm - 03:15pm

An overview of competing risks data, with applications in clinical trials

Jason Fine, The University of North Carolina at Chapel Hill, USA

03:15pm - 03:45pm

--- Coffee Break ---

03:45pm - 05:00pm

A general framework for sequential and adaptive methods in survival studies (PDF)

Zhiliang Ying, Columbia University, USA

Friday, 28 Oct 2011

08:45am - 09:00am

Registration

 

Chair: Say Beng Tan, National Medical Research Council

09:00am - 10:15am

Interim analyses that get it wrong (PDF)

Simon Day, Roche Products Limited, UK

10:15am - 10:45am

--- Coffee Break ---

10:45am - 12:00nn

Causal effects based on randomized clinical and intervention trials (PDF)

Alan Hubbard, University of California at Berkeley, USA

12:00nn - 02:00pm

--- Lunch ---

 

Chair: Jialiang Li, National University of Singapore

02:00pm - 03:15pm

Statistical challenges and adaptive design strategies in evaluation of new vaccines (PPT)

Ivan S. F. Chan, Merck Research Laboratories, USA 

03:15pm - 03:45pm

--- Coffee Break ---

03:45pm - 05:00pm

On regulatory statistics (PPT)

Peter Anthony Lachenbruch, Oregon State University, USA



Students and researchers who are interested in attending these activities are requested to complete the online registration form.

The following do not need to register:

  • Those invited to participate.


 Venue

 

 

Organizing Committee · Visitors and Participants · Overview · Activities · Venue

top
Best viewed with IE 7 and above