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Activity Number:
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238
- SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2018 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #327138
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Presentation
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Title:
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Sample Size Calculation for Pilot Studies
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Author(s):
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Chi-Hong Tseng* and Danielle SIM
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Companies:
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UCLA and UCLA
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Keywords:
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clinical trial;
pilot study;
sample size;
power
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Abstract:
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One important aspect in the design of clinical studies is to determine the sample size such that there is sufficient power in detecting clinically meaningful treatment effect. A pilot study can help in estimating the variability of the outcome to provide realistic parameters in the design of main studies. In this paper, we present a method to calculate the sample size for pilot studies to lead to realistic study design and adequate performance for the main studies. We derive the pilot study sample size formula according to the desired performance of the main studies and using simulations to demonstrate the performance of our method.
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Authors who are presenting talks have a * after their name.
