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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 - #305421 |
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Title:
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Use of Adaptive Clinical Trial Designs in Clinical Development for Product Registration
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Author(s):
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Laura Meyerson*+
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Companies:
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Biogen Idec
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Address:
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14 Cambridge Center, Cambridge, MA, 01746,
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Keywords:
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adaptive trial design
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Abstract:
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There has been recent recognition that adaptive trial designs can be useful in shortening the path of clinical development, thereby hastening patient access to efficacious products. Adaptive trial designs range in intent from selecting the optimal dose for which to continue the same study to selecting the correct sample size. Many companies have used these approaches in clinical development leading to a successful registration earlier than the more traditional design; others may have tried and failed. Of particular interest are those studies that have tried this approach for one or more of their registration trials (for example, a phase II/III trial). This luncheon is intended to bring together industry statisticians who have utilized or tried to utilize more adaptive approaches and to discuss their experiences, both successes in registration and/or failures.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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