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Novel Designs in Phase I Trials: A guide to scientifically acceptable and simple designs.

2. Outline. Existing Phase I DesignsIntroductionTraditional" DesignStorer's Up-and-Down" DesignsTwo-Stage DesignsAccelerated TitrationCombined Outcomes (Phase I/II Designs)Continual Reassessment MethodGeneral Design Considerations(Designs for Long-Term Toxicities)(Linked Phase I Trials)

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Novel Designs in Phase I Trials: A guide to scientifically acceptable and simple designs.

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    1. 1 Novel Designs in Phase I Trials: A guide to scientifically acceptable and simple designs. Rick Chappell, Ph.D. Professor, Department of Biostatistics and Medical Informatics and Department of Statistics University of Wisconsin School of Medicine and Public Health 2009 AACR/ASCO Vail Workshop

    2. 2 Outline Existing Phase I Designs Introduction “Traditional” Design Storer’s “Up-and-Down” Designs Two-Stage Designs Accelerated Titration Combined Outcomes (Phase I/II Designs) Continual Reassessment Method General Design Considerations (Designs for Long-Term Toxicities) (Linked Phase I Trials) Conclusion

    3. 3 Outline Existing Phase I Designs Introduction “Traditional” Design Storer’s “Up-and-Down” Designs Two-Stage Designs Accelerated Titration Combined Outcomes (Phase I/II Designs) Continual Reassessment Method General Design Considerations (Designs for Long-Term Toxicities) (Linked Phase I Trials) Conclusion

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