Symposium: Short Courses
| Short Course Daily Schedule for both Saturday and Sunday | |
| 7:00–8:00 AM | Continental Breakfast, Check-In and Registration, Prefunction Area |
| 8:00–10:00 AM | Short Course Session, Willow Rooms A & B |
| 10:00– 10:30 AM | Break, Prefunction Area |
| 10:30 AM–12:00 PM | Short Course Session, Willow Rooms A & B |
| 12:00–1:00 PM | Buffet Lunch, Grand Ballroom C |
| 1:00–3:00 PM | Short Course Session, Willow Rooms A & B |
| 3:00–3:30 PM | Break, Prefunction Area |
| 3:30–5:00 PM | Short Course Session, Willow Rooms A & B |
| Saturday, November 20, 2010 | |
| 8:00 AM–5:00 PM Willow A, 2nd Floor |
Short Course 1: “Statistical Design of Sequential Clinical Trials in R” Instructors: Scott Emerson and Daniel Gillen |
| Abstract: Increasingly, clinical trials are conducted using group sequential methods or, more recently, adaptive designs in order to address the ethical and efficiency issues that arise when performing experiments with human volunteers. The design, conduct, and analysis of a sequential clinical trial is necessarily more involved than that for a clinical trial in which the data would only be analyzed at the end of the study. In this short course we present the additional issues that must be considered when conducting a group sequential trial. The sequential methods are illustrated using RCT design, an R module for the design, monitoring, and analysis of clinical trials, and we illustrate how many prospective adaptive designs can be evaluated using these routines. | |
| 8:00 AM–5:00 PM Willow B, 2nd Floor |
Short Course 2: “The Use of Genetic Marker Data in Clinical Trials” Instructors: Bruce Weir and Patrick Heagerty |
| Sunday, November 21, 2010 | |
| 8:00 AM–5:00 PM Willow A, 2nd Floor |
Short Course 3: “Data Monitoring Committees: A Practical Approach” Instructors: Susan Ellenberg, Thomas Fleming and David DeMets |
| Abstract: For clinical trials evaluating interventions that could affect mortality or major morbidity, there has been increasing recognition that Data Monitoring Committees (DMCs) have an important role in safeguarding patient interests and enhancing trial integrity and credibility. In this short course, we will discuss how and why DMCs are critical to the ethics, efficiency, integrity and credibility of the process of monitoring accumulating data. After providing a background regarding the evolution of the use of DMCs, we will provide in depth discussion to motivate their use, and consider some fundamental principles regarding their function. Factors in constituting DMCs will also be carefully considered. Structural, functional and logistical issues will be considered. Ethical, philosophical and regulatory will be examined, including a review of guidances on DMCs that have been developed by regulatory authorities, and other government bodies and health organizations. Finally, many controversial issues will be explored, including the importance of confidentiality, the need for DMCs to be unblinded in their review, the DMC’s involvement in implementation of “adaptive” monitoring procedures, and the importance of currentness of data. Many real world examples will be used to illustrate key issues and enlighten the discussion. | |
| 8:00 AM–12:00 PM Willow B, 2nd Floor |
Short Course 4: “Statistical Evaluation of Markers for Classification and Prediction” Instructor: Margaret Pepe |
| Abstract: This course gives a broad overview of statistical issues in evaluating accuracy of medical tests and markers for diagnostic and prognostic applications. The objective is to present concepts that are important for study design and analysis. Concepts covered include: a) A phased paradigm for developing a classifier; b) Simple summaries of classifier performance (ROC curves); c) Estimating and Comparing ROC curves; d) Sample size calculations; e) Matching cases and controls; f) Adjusting for covariates; g) Different roles for covariates in evaluating markers; h) Quantifying the performance of risk prediction models.
Students should learn to appreciate basic strategies for evaluating classifier accuracy and become aware of resources available to implement methodologies. The course does not specifically address analysis of discovery studies. The focus is on evaluation of performance rather than on exploration. |
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| 1:00–5:00 PM Willow B, 2nd Floor |
Short Course 5: “Practice Issues in the Conduct and Reporting of Large-Scale Clinical Trials: The Women’s Health Initiative Experience” Instructors: Garnet Anderson and Andrea LaCroix |