Forms: Download Registration Form in either: Microsoft Word or Adobe PDF format
Held On: December 4 - 5, 2006
Location:
Hilton Newark Airport
1170 Spring Street, Elizabeth, NJ 07201-2114

Overview

Obesity is a serious condition that is associated with and believed to cause much morbidity, reduced quality of life, and decreased longevity. The most recent figures from the Centers for Disease Control indicate that obesity continues to increase in prevalence in the overall US population. Currently available treatments are only modestly efficacious and rigorously evaluating new (and in some cases existing) treatments for obesity are clearly in order. Conducting such evaluations to the highest standards and so that they are maximally informative requires an understanding of best methods for the conduct of randomized clinical trials in general and how they can be tailored to the specific needs of obesity research in particular. In response to recent Medicare calls for increased evaluation of obesity treatments, an FDA meeting on open questions in the conduct of obesity treatment trials, and high profile editorials in general medical journals questioning the way we design, execute, analyze, and interpret randomized clinical trials in obesity research, we will offer a two-day meeting in which leading obesity researchers and methodologists convene to discuss best practices for randomized clinical trials in obesity.

Women, members of underrepresented minority groups and individuals with disabilities are strongly encouraged to apply.

Tuition is $100 for attendees from academic, government, and not-for-profit organizations and $850 for attendees from for-profit companies and does not include the cost of food, travel or lodging. Limited funds are available on a competitive basis for travel scholarships with preference given to graduate students and post-doctoral fellows.

Registration will be limited to 100, so please apply prior to Sun 10/15/2006. Accepted applicants will be notified by Fri 10/20/2006.

Schedule of Events

DateTimeSpeaker/ModeratorTopicResources
Dec. 4, 2006 8:00 a.m.-8:05 a.m. David B. Allison, Ph.D.
University of Alabama at Birmingham
Announcements/Business  
I. What are the Objectives?
8:05 a.m.-8:15 a.m. Donna Ryan, M.D.
Pennington Biomedical Research Center
Overview by Moderator Watch Video
8:15 a.m.-8:55 a.m. Gary D. Foster, Ph.D.
Temple University
The Patient/Consumer Perspective. What risks are perceived to be tolerable? What weight losses are considered acceptable given the costs of obtaining them? What duration of weight maintenance is judged to be of value? Watch Video
8:55 a.m.-9:35 a.m. Dympna Gallagher, Ed.D.
New York Obesity Research Center, Columbia University
Body weight and composition. How much weight needs to be lost? Should body composition measures replace body weight as primary outcomes and, if so, which measures should be used? Watch Video
9:35 a.m.-9:50 a.m. Break
9:50 a.m -10:30 a.m. Barbara Rolls, Ph.D.
Pennsylvania State University
Intermediary behavioral endpoints. Is there value in measuring intermediary behavioral endpoints such as hunger, energy intake, and physical activity. If so, how might they be measured? Watch Video
10:30 a.m.-11:10 p.m. Donna Ryan, M.D.
Pennington Biomedical Research Center
Safety monitoring. How should safety be monitored? Are there key adverse events or side-effects that should always be carefully assessed? Watch Video
11:10 a.m -11:50 a.m. David B. Allison, Ph.D.
University of Alabama at Birmingham
Empirical evidence and issues specific to the design and analysis of obesity treatment trials. Watch Video
11:50 a.m.-12:10 p.m. All speakers led by Moderator Panel Discussion  
12:10 p.m.-1:25 p.m. Lunch
Dec. 4, 2006 II. Design: Statistical Aspects
1:25 p.m -1:40 p.m. David B. Allison, Ph.D.
University of Alabama at Birmingham
Overview by Moderator  
1:40 p.m -2:20 p.m. Sherri P. Pals, Ph.D.
Centers for Disease Control and Prevention
Design of Group Randomized Trials (GRTs). When are GRTs most appropriate? How can GRTs be most efficiently designed? Watch Video
2:20 p.m -3:00 p.m. Shumei Sun, Ph.D.
Wright State University
Duration & Sample Size. How long should trials be and how large? Watch Video
3:00 p.m -3:15 p.m. Break
3:15 p.m -3:55 p.m. Christopher S. Coffey, Ph.D.
University of Alabama at Birmingham
Frequentist Adaptive Designs, Internal Pilots, ad Stopping Rules. Can study designs be optimized by being made adaptive? Watch Video
3:55 p.m -4:35 p.m Donald A. Berry, Ph.D.
UT M. D. Anderson Cancer Center
Bayesian Adaptive Designs. How can a Bayesian statistical approach enhance efficiency and interpretability. Watch Video
4:35 p.m -5:15 p.m. Steven B. Heymsfield M.D.
Merck Research Laboratories
Why do Obese Patients Not Lose More Weight When Treated With Low-Calorie Diets? A Mechanistic Perspective Watch Video
5:15 p.m -5:35 p.m. All speakers led by Moderator Panel Discussion  
Dec. 5, 2006 8:00 a.m.- 8:05 a.m. David B. Allison, Ph.D.
University of Alabama at Birmingham
Announcements/Business  
III. Design: Non-Statistical Aspects
8:05 a.m.-8:15 a.m. Kishore Gadde, M.D.
Duke University
Overview by Moderator  
8:15 a.m.-8:55 a.m. Kishore Gadde, M.D.
Duke University
Choice of control condition. How rigorous should the control group’s treatment be? Should treatments always be compared to rigorous diet and exercise programs or is minimal treatment more appropriate? How does the choice affect results? Watch Video
8:55 a.m.-9:35 a.m. Rena Wing, Ph.D.
Brown University
Handling drop-outs. How can drop-outs be minimized and when they occur how can one still obtain the outcome measures? The clinical perspective: Are we interested in estimating effects of treatment assignment or the effects of treatment? Watch Video
9:35 a.m.-9:50 a.m. Break
9:50 a.m.-10:30 a.m. Jamy D. Ard, Ph.D.
University of Alabama at Birmingham
Special Issues in Studying Minority Groups. What issues arise when studying minority groups? How, if at all, should studies of ethnic minorities be differentially designed? Watch Video
10:30 a.m.-11:10 a.m. Robert Berkowitz, M.D.
University of Pennsylvania
Special Issues in Studying Children. What issues arise when studying children? How might studies of children be differentially designed? Watch Video
11:10 a.m.-11:50 a.m. F. Xavier Pi-Sunyer, M.D.
Columbia University
Inclusion & Exclusion Criteria.hich subjects should be studied? Should people with comorbidities be excluded, included, or studied in separate trials? Should there be age and BMI limits? Watch Video
11:50 a.m.-12:10 p.m. All speakers led by Moderator Panel Discussion  
12:10 p.m.-1:45 p.m. Lunch
Dec. 5, 2006
IV. Analysis & Interpretation
1:45 p.m.- 2:00 p.m. F. Xavier Pi-Sunyer, M.D.
Columbia University
Overview by Moderator  
2:00 p.m.- 2:40 p.m. Diane Catellier, Ph.D.
University of North Carolina, Chapel Hill
Intent to treat analysis. Why it is critical and approaches to getting it done beyond last observation carried forward. Watch Video
2:40 p.m.- 2:55 p.m. Break
2:55 p.m.- 3:35 p.m. Gary L. Gadbury, Ph.D.
University of Missouri at Rolla
Treatment response heterogeneity. How much variability in response to treatment is there? How can we test for it? What are the implications? Watch Video
3:35 p.m.- 4:15 p.m. Timothy Lohman, Ph.D.
University of Arizona
What constitutes adequate evidence for long-term effect? Watch Video
4:15 p.m.- 4:55 p.m. Judy Stern, Sc.D.
University of California, Davis
Evidence from a consumer and regulatory perspective: From RCTs to Testimonials Watch Video
4:55 p.m.- 5:15 p.m. All speakers led by Moderator Panel Discussion  

Speakers

  • David B. Allison, Ph.D., UAB
  • Jamy D. Ard, M.D., UAB
  • Christopher Coffey, Ph.D., UAB
  • Robert Berkowitz, M.D., University of Pennsylvania
  • Donald A. Berry, Ph.D., UTMD Anderson Cancer Center
  • Diane Catellier, Ph.D., University of North Carolina Chapel Hill
  • Gary D. Foster, Ph.D., Temple University
  • Gary L. Gadbury, Ph.D., University of Missouri at Rolla
  • Kishore Gadde, M.D., Duke University
  • Dympna Gallagher, Ed.D., NY Obesity Rsrch Cntr, Columbia University
  • Timothy Lohman, Ph.D., University of Arizona
  • Steven B. Heymsfield M.D., Merck Research Laboratories
  • Sherri P. Pals, Ph.D., Centers for Disease Control & Prevention
  • F. Xavier Pi-Sunyer, M.D., Columbia University
  • Barbara Rolls, Ph.D., Pennsylvania State University
  • Donna Ryan, M.D., Pennington Biomedical Research Center
  • Shumei Sun, Ph.D., Wright State University
  • Judy Stern, Sc.D., University of California, Davis
  • Rena Wing, Ph.D., Brown University

Contact Information:

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Sponsors:
Clinical Nutrition Research Center,
University of Alabama at Birmingham

Funding for this conference was made possible (in part) by (1 R13 DK077555-01) from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI). The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention by trade names, commercial practices, or organizations imply endorsement by the U.S Government.