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2006 Conferences

Design, Analysis, and Interpretation Of Randomized Clinical Trials In Obesity (Dec 4-5, 2006)

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
1-800-HILTONS (+ 1-800-445-8667) phone, (908) 351-9716 fax   
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:

RealPlayer is required to view video presentations.

DATE    TIME    SPEAKER/MODERATOR    TOPIC    RESOURCE(S)   
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    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?    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?    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?    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?    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.    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   
DATE    TIME    SPEAKER/MODERATOR    TOPIC    RESOURCE(S)   
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?    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?    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?    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.    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    video    
5:15 p.m -5:35 p.m.    All speakers led by Moderator    Panel Discussion     
DATE    TIME    SPEAKER/MODERATOR    TOPIC    RESOURCE(S)   
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?    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?    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?    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?    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?    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   
DATE    TIME    SPEAKER/MODERATOR    TOPIC    RESOURCE(S)   
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.    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?    video    
3:35 p.m.- 4:15 p.m.    Timothy Lohman, Ph.D.
University of Arizona    What constitutes adequate evidence for long-term effect?    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    video    
4:55 p.m.- 5:15 p.m.    All speakers led by Moderator    Panel Discussion     

UAB Speakers:

David B. Allison, Ph.D.    Jamy D. Ard, M.D.   
Christopher Coffey, Ph.D.     

External Speakers:

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 Univ.    Steven B. Heymsfield M.D.
Merck Research Laboratories   
Timothy Lohman, Ph.D.
University of Arizona    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:

Logistics: Richard Sarver
University of Alabama at Birmingham
1665 University Blvd, RPHB 414
Birmingham, AL 35294-0022
Phone: (205) 975-9169
Email: rsarver@uab.edu   
Scientific: David B. Allison, Ph.D.
University of Alabama at Birmingham
1665 University Blvd, RPHB 420C
Birmingham, AL 35294-0022
Phone: (205) 975-9169
Email: dallison@uab.edu   

Funded by:

National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)   
National Cancer Institute (NCI)   

Sponsors:

http://www.uab.edu/cnrc 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.   

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