Adaptive Clinical Trial Case Studies
Alert:
Although adaptive clinical trials allow for faster go/no-go decisions, tend to be more ethical and can save lots of time and money, the risks of collecting bad data are high. Just one mistake can corrupt your data.
So what can you do to make certain you collect your trial data the right way — every time?
In this 90-minute audio CD/transcript, Cyrus Mehta, Ph.D., cofounder and president of Cytel Inc., will present three in-depth case studies where an adaptive design was used to modify the initial assumptions and improve the design, using interim data from the trial itself.
In each of these studies, he will describe the trial endpoints, trial methodology, data examination frequency and number of patients required.
In addition, Cyrus will delve deeper into each study by:
- Discussing the logistical problems of adaptive clinical trials and methods to control for bias
- Showing how to make mid-course corrections to sample size
- Explaining the statistical problems of adaptive clinical trials, and methods to control for excess false positives and excess false negatives
- Demonstrating how to detect early signals for efficacy or futility
All of this valuable information will be presented to you in an approachable manner, with real-world applications.
Don't risk the integrity of your trial, find out how to ensure clean data every time.
Cyrus Mehta, Ph.D., is cofounder and president of Cytel Inc. He is chiefly responsible for creating Cytel's East® system used to design, simulate and monitor adaptive clinical trials. An influential biostatistical thought leader, he has dedicated his research toward developing innovative methods and software for flexible clinical trials, including group sequential and adaptive trials. A much sought after speaker on the topic of designing adaptive clinical trials, he is often engaged to train major biopharmaceutical, academic and FDA biostatisticians in the latest adaptive methodologies.
Cyrus is a fellow of the American Statistical Association, and has over 70 reviewed statistical published papers to his credit. Since 1979, he has been a faculty member at the Harvard School of Public Health Department of Biostatistics. He holds degrees from MIT, Harvard and the Indian Institute of Technology.
This audio CD/transcript is a must for statistics consultants, as well as professionals in drug, biotech, biologic, device, and diagnostics companies including:
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