AGENDA   Monday, March 7, 2005 8:00 a.m. - 4:00 a.m. Bethesda Marriott Suites, Room TBD Moderators: Jim Neaton and Desmond Schatz       Click here to download a PDF Version of the Agenda. (Requires Adobe Acrobat Reader.)       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 β-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
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