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Activity Number:
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296
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Type:
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Luncheons
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Date/Time:
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Tuesday, August 8, 2006 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305697 |
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Title:
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The Use of Targeted Designs in Clinical Trials
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Author(s):
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Gerald Crans*+ and Matthew Rotelli
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Companies:
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Eli Lilly and Company and Eli Lilly and Company
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Address:
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389 Arbor Drive, Carmel, IN, 46032,
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Keywords:
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targeted design ; sample size ; efficiency
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Abstract:
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The cost of drug development has increased markedly over the last decade. Unfortunately, the rate of new drug approvals has not kept up with these costs. This has aroused the ire of pharmaceutical executives and health wary consumers, as the availability of novel agents was not as expected and profits have not materialized. A potential improvement to clinical research---which could reduce costs, increase the probability of technical success, and enhance feasibility---is possible by using targeted designs. These designs use variables collected during screening to enroll only subjects expected to respond to treatment. This could lower costs by reducing the number of subjects needed for enrollment, potentially making viable those clinical trials that were impossible before. The advantages and disadvantages of these designs will be discussed at the roundtable.
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