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Summer Program: Statistics in the Health Sciences

Weeks 4 & 5

Design and Analysis of Clinical Trials

July 28 -August 7, 1997

Organizers:

Donald A. Berry, (Duke University)
Marvin Zelen (Harvard University)


Workshop Schedule Confirmed speakers and visitors Registration Form
Accomodations

Clinical investigations remains the single most important medical tool to evaluate and compare various therapies. This includes the design and analysis for drug and vaccine development, and for evaluation of the efficacy and safety of therapeutic agent and vaccines. The issues involved include early stopping (interim analysis), censoring missing data, problems of compliance, competing trials, intermediate endpoints, surrogate markers univariate and multivariate survival analysis. Among the issues of interest are: the design of clinical investigations beginning with an understanding of drug mechanisms through pharmacokinetics/dynamics studies, and the assessment of drug safety and efficiency (i.e., the design of Phase I, III, IV studies). We are also interested in the design of prevention and vaccine trials. A particular challenging problem in the design of trials with multivariate endpoints.

Schedule for Weeks 4 and 5

All talks are in Vincent Hall Room 570 unless otherwise noted.
SCHEDULE for MONDAY, JULY 28
8:45 am Registration and Coffee IMA Lounge, Vincent Hall 502
9:15 am A. Friedman, R. Gulliver, D. Berry Welcome and Orientation
9:45 am Marvin Zelen,
Harvard School of Public Health
The Theory and Practice of Clinical Trials
10:45 am Break IMA Lounge, Vincent Hall 502
11:15 am John Simes,
University of Sydney
Design strategies for handling several similar randomized trials addressing common treatment questions
2:00 pm Richard Simon,
National Cancer Institute
Bayesian Analysis of Active Control Clinical Trials
4:00 pm IMA Tea Vincent Hall 502 (IMA Lounge)
SCHEDULE for TUESDAY, JULY 29
9:15 am Coffee IMA Lounge, Vincent Hall 502
9:30 am Roger J. Lewis,
UCLA School of Medicine
A Bayesian Approach to the Analysis of a Randomized Prehospital Clinical Trial
10:30 am Coffee IMA Lounge, Vincent Hall 502
11:00 am Donald A. Berry,
Duke University
Using Historical Controls, Decision Making, and Adaptive Designs in Clinical Trials
2:00 pm Discussion Session Richard Simon, Donald Berry and Roger Lewis
SCHEDULE for WEDNESDAY, JULY 30
9:15 am Coffee IMA Lounge, Vincent Hall 502
9:30 am Gregory Campbell,
FDA/Devices & Radiol. Health
The Unique Challenges of Medical Devices to Clinical Trials
10:30 am Break IMA Lounge, Vincent Hall 502
11:00 am Constantine Gatsonis,
Brown University
Clinical evaluations of diagnostic technology
2:00 pm Discussion Session Gregory Campbell, Constantine Gatsonis
SCHEDULE for THURSDAY, JULY 31
9:15 am Coffee IMA Lounge, Vincent Hall 502
9:30 am Dalene K. Stangl,
Duke University
The Use of Reference Priors and Bayes Factors in the Analysis of Clinical Trials
10:30 am Break IMA Lounge, Vincent Hall 502
11:00 am Amy Racine-Poon,
Pharma AG, Novartis
The use of population modeling in dose schedule recommendation
2:00 pm Discussion Session Dalene Stangl, Amy Rancine-Poone
5:00 pm Workshop Taco Party Courtyard Behind Vincent Hall
SCHEDULE for FRIDAY, AUGUST 1
9:15 am Coffee IMA Lounge, Vincent Hall 502
9:30 am Stan Young,
Glaxco Wellcome
The analysis of clinical trials with multiple outcomes
10:30 am Break IMA Lounge, Vincent Hall 502
11:00 am Ross L. Prentice,
Hutchinson Cancer Research Ctr.
Analysis of Multivariate Failure Time Data
2:00 pm Discussion Session Stan Young, Ross Prentice
WEEK 5
SCHEDULE for MONDAY, AUGUST 4
9:15 am Registration and Coffee IMA Lounge, Vincent Hall 502
9:30 am Elizabeth Halloran,
Emory University
Special Issues in Vaccine Field Studies
10:30 am Break IMA Lounge, Vincent Hall 502
11:00 am L.J. Wei,
Harvard School of Public Health
Play the Winner for Phase II/III Clinical Trials
2:00 pm Greg Baker,
Ohio State University
On the Nature of Singularity Formation During Vortex Sheet Motion
SCHEDULE for TUESDAY, AUGUST 5
9:15 am Coffee IMA Lounge, Vincent Hall 502
9:30 am Peter F. Thall,
M.D. Anderson Cancer Center
A Strategy for Dose--Finding and Safety Monitoring Based on Efficacy and Adverse Outcomes in Phase I/II Clinical Trials
10:30 am Coffee IMA Lounge, Vincent Hall 502
11:00 am Thomas A. Louis,
University of Minnesota
Data and decision based prior partitions with application to monitoring clinical trials
2:00 pm Discussion Session
L.J. Wei, Peter Thall and Thomas Louis
SCHEDULE for WEDNESDAY, AUGUST 6
9:15 am Coffee IMA Lounge, Vincent Hall 502
9:30 am Stephen L. George,
Duke University
Surrogate Endpoints in Cancer Clinical Trials
10:30 am Break IMA Lounge, Vincent Hall 502
11:00 am Stan Young,
Glaxo Wellcome Inc.
Recursive Partitioning Analysis of Clinical Data
2:00 pm John Simes,
University of Sydney
Design strategies for handling several similar randomised trials addressing common treatment questions
3:00 pm Discussion Session Stephen George, Stan Young, Johns Simes
5:00 pm Workshop Pizza Party Courtyard Behind of Vincent Hall
SCHEDULE for THURSDAY, AUGUST 7
9:15 am Coffee IMA Lounge, Vincent Hall 502
9:30 am Ping Hu,
Harvard School of Public Health
Planning Clinical Trials to Evaluate Early Detection Programmes
10:30 am Break IMA Lounge, Vincent Hall 502
11:00 am Ori Davidov,
Hutchinson Cancer Research Ctr.
Mathematical Models in the Design of Cancer Prevention Trials
2:00 pm Discussion Session Ping Hu, Ori Davidov


Week 1: Genetics
July 7-11, 1997

Week 2: Imaging
July 14-17, 1997

Week 3: Diagnosis & Prediction
July 21-25, 1997

Weeks 4 & 5: Design & Analysis of Clinical Trials
July 28 - August 7, 1997

Week 6: Statistics & Epidemiology:Environment and Health
August 18-21, 1997

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