Adaptive Clinical Trial Design 10 Reasons to Use Adaptive Designs in Dose Ranging Studies
$327.00
Product Details
New techniques are helping drugmakers pinpoint Phase III dosages and increasing clinical trial success. Discover how you can
cut clinical trial costs and boost profits. Read on ...
Savvy drugmakers are using sophisticated computer modeling and forecasting to home in on appropriate dosages. They’re boosting Phase III trial
success and cutting trial costs with advanced computer modeling and forecasting techniques that cut dosage guesswork.
FDAnews has enlisted a top expert on adaptive clinical trials, Olga Marchenko, to walk you through three adaptive-design
methods for dose ranging studies. You’ll discover:
- A technique to find a single dose for Phase III trials that minimizes the rate of adverse events and maximizes the number of efficacy responses
- The two adaptive methods ― capabilities and limitations of each
- Thall and Cook (Biometrics, 2004) is a an outcome-adaptive Bayesian method that uses both efficacy and toxicity to choose the best results
- Dragalin and Fedorov (JSPI) models the distribution of bivariate binary endpoints
- How to create simulations that compare characteristics of each design
- An easy and free way to perform simulations that illustrate examples of the various methods
- 2 in-depth case studies ― in cardiovascular and pain
- Case Study 1 (cardiovascular): Find a single dose to use for Phase III study that jointly maximizes the rates of efficacy response and minimizes the rates of AE of special interest
- Case Study 2 (acute postoperative pain): Provide information on the dose-response relationship of the drug combination and choose the combination doses to take to the confirmatory trial
Get set for 90 minutes of nonstop learning. And don’t forget your questions! Because this session is web-based and totally interactive, you can email questions and get answers by the time you and your staff log off.
That’s right: As many staffers may participate from one location as you like. Since there’s no extra charge ― even if hundreds participate ― it makes sense to invite every executive and staffer with clinical trial responsibilities.