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Activity Number: 315 - SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 9:25 AM to 10:10 AM
Sponsor: Biopharmaceutical Section
Abstract #332545
Title: Sample Size Calculation for Pilot Studies
Author(s): Chi-Hong Tseng* and Danielle SIM
Companies: UCLA and UCLA
Keywords: clinical trial; pilot study; sample size; power

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.

Authors who are presenting talks have a * after their name.

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