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Activity Number:
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219
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Type:
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Contributed
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Date/Time:
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Tuesday, August 5, 2003 : 9:00 AM to 10:50 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301925 |
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Title:
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How Many Local Ethnicity Participants are Needed to Preserve the Significant Results from the Complete Clinical Data Package in Bridging Study?
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Author(s):
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Chee Jen Chang*+ and Shen Jang Fann
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Companies:
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National Taiwan University Hospital and IBMS Academia Sinica
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Address:
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4401 5E West Campus, Taipei, Taiwan, 100, Taiwan
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Keywords:
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Bridging study ; CCDP ; ICH ; sample size
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Abstract:
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Bridging study is an evaluation procedure when a foreign medication is to launch in a new region. Most countries heavily rely on imported efficacious medications not only need to concern the efficacy, but also the ethnicity. ICH-E5 clearly indicated guidelines using Bridging study to extrapolate foreign data into local regions. How to achieve "similarity" between local and foreign regions using data in complete clinical data package (CCDP) can be examined statistically. A method calculating the minimum number of local subjects required to preserve the significant result from the CCDP is proposed. To prove the efficacy similarity between data in foreign and local regions in CCDP is analogous to preserve the statistical significant property both in population and subgroup with sample size N, n. Simple random sampling is used to derive the minimum sample size. Necessary and sufficient condition for sample size needed to preserve the statistical significance in a smaller subset of CCDP can be derived from an inequality and from Monte Carlo simulations. Comparison of this approach with sample size calculation proposed by Levy (1980) is made and will be presented.
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