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Activity Number: 486
Type: Contributed
Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #309784
Title: Small-Scale Studies and Their Impact on Phase III Trials: Vanguards, Pilot Studies, and Run-Ins
Author(s): Sarah Baraniuk*+
Companies: UT-School of Public Health
Keywords: Clinical Trials ; Vanguard ; Pilot Studies ; Clinical Trial Design ; Phase III
Abstract:

Typically Phase III Randomized Clinical Trials (RCTs) are large scale trials used to determine the efficacy or effectiveness of interventions and are generally considered the best study design option for making definitive statements regarding treatment effect. Before embarking on a Phase III trial the rationale and justification of the need for a Phase III must be firmly established. Since Phase III RCTs are often costly and time consuming, frequently the researchers feel the need to incorporate small scale studies before or at the onset of the main study, e.g., via a pilot study, run-in phase, or vanguard phase. These terminologies have been used interchangeably in literature. Our objective is to provide a clear perspective on each of these important types of studies and indicate how the information obtained can be used in the main study.


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