The Risks and Benefits of Adaptive Trials: Part 2

The simple Excel spreadsheet shows accumulating data that are projected to predict a quantity at some point in the future. It’s not crystal ball statistics, its adaptive design in action. You could be charting:

a) Enrollment rate of a trial.
b) Time to completion of a trial.
c) Number of adverse events in a trial.

And your daily predictions of the future will guide you in making decisions, such as if you should you add another investigative site;   close a site down, or add regulatory staff because the trial will be done early? If even a simple spreadsheet can use adaptive designs to predict the future, maybe you should too.

The storyline:
Just returning from a reconnaissance mission where he discussed the use of Bayesian analysis and adaptive trial designs with an esteemed faculty of FDA experts, our speaker, Dr. Robert Thiel’s objective is to tell you how to apply adaptive designs the FDA way. In this informative and timely follow-up presentation*, he’ll also tell you if you should apply adaptive designs by using real-life and hypothetical examples of how they can work for you or against you.

Do you have to be a statistician to attend? Absolutely not! Our speaker is an accomplished communicator who can make adaptive designs understandable to anyone.

*Part 1 of this series “An Introduction to Bayesian Statistics” laid the groundwork for understanding the difference between Bayesian vs frequentist statistics.

The resolution:
Then he'll will follow with some practical talk about the impact of adaptive designs on the rest of the project team: will clinical, regulatory, and other team professionals have to do anything differently in their jobs?

The playbill:
Each audience member will receive:
1. PowerPoint slides.
2. An expert speaker.
3. Chance to listen to other's Q&A.
4. CEUs and certificate of attendance.

The characters:
Dr. Robert P. Thiel. has degrees in physics, clinical counseling and psychometrics. He is an expert in the analysis of IVD data for the Medical Device Industry with more than 75 510K and 5 PMA approvals. He has published papers in the area of free PSA, breast cancer, ovarian cancer, liver disease and multivariate analyses. His current interests lie in the area of bootstrap and permutation test methodology and the application of these methods to small sample trials and Bayesian analysis as applied to diagnostic clinical trials. Dr. Thiel can be contacted at rpthiel@thielstatcon.com.

Audience suitability:
[x] Statistical professionals
[x] Non-statisticians interested in the subject
[x] Clinical research professionals who design clinical trials
[x] Regulatory professionals who report clinical data
[x] Managers who sign-off on clinical trials
[x] Executives who are planning their companies futures

The purchase is $420 for OnDemand access and $470 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.