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This is the preliminary program for the 2007 Joint Statistical
Meetings in Salt Lake City, Utah.
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The views expressed here are those of the individual authors and not necessarily those of the ASA or its board, officers, or staff. Back to main JSM 2007 Program page |
= Applied Session,
= Theme Session,
= Presenter| CE_23C | Tue, 7/31/07, 8:30 AM - 5:00 PM | CC-151 G |
| Statistical Monitoring of Clinical Trials: A Unified Approach - Continuing Education - Course | ||
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Biopharmaceutical Section, ASA |
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| Instructor(s): Michael Proschan, National Institute of Allergy and Infectious Diseases | ||
| This course uses the B-value approach to show how to monitor many different types of trials, including those with continuous, dichotomous, or survival endpoints, with or without adjustment for covariates. This means that the same boundaries can be used for the different types of trials. Moreover, we show that calculations performed under the alternative hypothesis depend only on the expected value of the z-score at the end of the trial. We use this to show how to compute and interpret conditional and unconditional power, which are very useful in deciding whether to stop a trial for futility. We then cover different monitoring boundaries (including the flexible error spending function approach), inference following a group-sequential trial (p-values, estimation, confidence intervals), some Bayesian methods, and some adaptive sample size methods. Although the B-value paradigm is applicable in most situations, there are some in which it does not, such as when the sample sizes are too small. We discuss what to do in these cases as well. Recommended Textbook: Proschan, M.A., Lan, K.K.G., and Wittes, J.T. (2006). Statistical Monitoring of Clinical Trials: A Unified Approach. Springer. ISBN: 978-0-387-30059-7 | ||
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JSM 2007
For information, contact jsm@amstat.org
or phone (888) 231-3473. If you have questions about the Continuing Education program,
please contact the Education Department. |