Adaptive Clinical Trial Design 10 Reasons to Use Adaptive Designs in Dose Ranging Studies

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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.
  • Clinical project specialists
  • Clinical research associates
  • Data management and statistics personnel
  • Regulatory/legislative affairs professionals
  • Study research coordinators
  • Clinical portfolio management
  • Executive management
  • Physicians/chief medical officers

FDAnews has hosted this webinar in the past to strong industry interest. If you missed it the first time around, here’s a second chance. Discover the 10 reasons to use adaptive designs in dose ranging studies.

Olga Marchenko is Director of Biostatistics at i3 Statprobe Inc. and head of the Adaptive Design Consulting Group. A leading expert working with clients and statisticians on adaptive design methodology, she provides strategic leadership for design and analysis of clinical trials and is the senior statistical oversight person on client projects and statistical consulting services. She is a former Pfizer executive with more than 100 clinical trials under her belt.

Register now!

Date: Nov. 9–27, 2009
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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