Biostatistical Issues and the Design of Type 1 Diabetes TrialNet
March 7, 2005,
Bethesda, MD
Summary
This meeting will convene experts in the areas of biostatistics, endocrinology, and clinical trials to discuss creative approaches to protocol design so that multiple trials can successfully be performed concurrently and rigorously within the TrialNet network
Agenda
Monday, March 7, 2005 8:00 a.m. - 4:00 a.m.
Bethesda Marriott Suites,
Moderators: Jim Neaton and Desmond Schatz
Introduction
7:30 a.m. - 8:00 a.m. Sign-In and Light Refreshments
8:00 a.m. - 8:15 a.m. Meeting Goals: What We Hope To Accomplish Des Schatz
8:15 a.m. - 8:30 a.m. Where We Are
- mission of TrialNet
- number of sites
- potential patient base
- screening effort required for trials
- natural history (description of T1DM pathogenesis) and measurement of ?-cell function
- issues in prevention studies, early onset studies, and studies of patients with long history of T1DM
- current TrialNet studies
Jay Skyler
Design Issues in Clinical Trials
8:30 a.m. - 9:10 a.m. Surrogate Endpoints: The Challenges Are Greater Than They Seem (10-minute discussion) Tom Fleming
9:10 a.m. - 9:50 a.m. Some Phase 23 Designs (10-minute discussion) Peter Thall
9:50 a.m. - 10:20 a.m. What About the Effect Size? (10-minute discussion) Jeff Mahon
10:20 a.m. - 10:30 a.m. Break
10:30 a.m. - 11:00 a.m. Discussion of Fleming, Thall, and Mahon Butch Tsiatis
11:00 a.m. - 12:00 noon Panel Discussion Tom Fleming, John Lachin, Jeff Mahon, Dave Reboussin, Rich Simon, Peter Thall, Butch Tsiatis
12:00 noon - 1:00 p.m. *Lunch* (On Your Own)
TrialNet Design Issues
1:00 p.m. - 1:30 p.m. POPPI 1 Study as an Example
(15 minute each) Mark Espeland, Joan Hilton, Tom Louis Panel and
General Discussion Mark Espeland, Carla Greenbaum, Joan Hilton, John Lachin, Tiepu Liu, Tom Louis, Jeff Mahon, Jerry Palmer, Des Schatz, Jay Skyler
Summary
3:30 p.m. - 4:00 p.m. Meeting Summary Herman Mitchell Final Comments Des Schatz
4:00 p.m. Adjournment Return to top
Contact Information
Ellen Leschek, M.D.
Type 1 Diabetes TrialNet Program
Health of Institutes National Diseases Kidney and Digestive Diabetes Institute
Email: lescheke@extra.niddk.nih.gov
Phone301-435-6047 or 301-480-3503
Bethesda MD
Page last updated: May 05, 2008
