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Events
Webinar - The Use of Large Simple Trials to Answer Comparative Effectiveness Research and Safety Questions
Date: December 8, 2011
10 AM ET
Click here to register.
Large simple trials (LSTs) are defined as prospective, interventional, randomized trials that use large numbers of patients, broad inclusion criteria, multiple study sites, observational follow-up, and minimal data requirements to follow detection of small treatment effects, rare events, and improved external validity. While patient registries and other observational designs receive much attention for their ability to deliver real-world evidence for safety and effectiveness, LSTs are less common and are not typically deployed in outcomes research. However, the randomization component of LSTs and their sample sizes may deliver quality data that reaches beyond that of other observational designs while still being generalizable to the reference population.
This webinar will highlight the applications and design elements of LSTs (including an exploration of the design differences between typical randomized trials, LSTs and other observational designs). A survey of the literature and of public sources such as www.clinicaltrials.gov will describe the objectives addressed in LSTs to-date, motivations for undertaking the LSTs (mandated by regulatory authority, requested by payors), common therapeutic areas for these studies, as well as trends in their use over time. The session will focus on case examples, drawn from the literature and from different organizations’ experiences, of LSTs and how their results have addressed comparative effectiveness and safety questions. LSTs will be placed in context within the evidence spectrum and future applications for this design will be explored.
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