Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| CE_47T | Wed, 8/6/2014, 1:00 PM - 2:45 PM | W-Alcott | |
| Clinical Trial Simulation and Design Using the Facts Platform — Professional Development Computer Technology Workshop | |||
| ASA | |||
| In all but the simplest of designs, trial simulation is an invaluable tool for the assessment of operating characteristics and performance of trial designs. As the complexity of the design increases (e.g., for adaptive dose-finding designs, designs with early stopping) and as the uncertainty around the design parameters increases (e.g. accrual rates), simulation becomes imperative. Additionally, we often have broad and possibly evolving goals and settings for the trial. So the ability to rapidly simulate and explore a wide set of variations of a design is crucial. The FACTS platform is a suite of programs that enables the user to define and simulate a large class of trials that encompass a range of features including fixed and Bayesian adaptive designs with continuous, dichotomous and time-to-event endpoints; clinical utility-based combination of multiple endpoints; enrichment designs, and dose-escalation. We will present examples to illustrate the process of designing a trial by iteratively simulating and exploring a range of designs using FACTS. The use of graphical displays of operating characteristics, and the importance of examining details of individual simulated trials will also be discussed. | |||
| Instructor(s): Scott Berry, Berry Consultants, Ashish Sanil, Berry Consultants | |||
2014 JSM Online Program Home
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