Institute for Mathematical Sciences Event Archive
Online registration form Enquiries |
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Workshop on the Design and Analysis of Clinical Trials
(24 - 28 October 2011)
Organizing Committee · Visitors and Participants · Overview · Activities · Venue
Chair
- Weng Kee Wong (University of California at Los Angeles)
Co-chairs
- Say Beng Tan (National Medical Research Council)
- Zhiliang Ying (Columbia University)
Members
- Jialiang Li (National University of Singapore)
- William Rosenberger (George Mason University)
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.
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 |
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08:30am - 09:00am |
Registration |
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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 --- |
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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 |
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08:30am - 08:50am |
Registration |
08:50am - 09:00am |
Opening Remarks |
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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 --- |
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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 |
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Singapore public holiday |
Thursday, 27 Oct 2011 |
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08:45am - 09:00am |
Registration |
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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 --- |
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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 |
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08:45am - 09:00am |
Registration |
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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 --- |
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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.
Organizing Committee · Visitors and Participants · Overview · Activities · Venue
