Adaptive Clinical Trial Design and Model-Based Drug Development

Held Nov. 10, 2011

Sign up now to attend this special 2-½ hour, two-part session: you’ll learn about the 10 reasons to use adaptive designs in dose-ranging studies, and 10 benefits of modeling and simulation in drug development.

And you’ll walk away with the tools you need to save your company time and money.

In its first extended-length 2 ½-hour webinar, FDAnews is pleased to bring you the latest on adaptive clinical trial design and model-based drug development.
Today’s 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 minimize dosage guesswork. Now you too can learn how to successfully cut your costs and boost your profits.

We’ve enlisted a top expert on adaptive clinical trials, Olga Marchenko, to walk you through three adaptive design methods for dose-ranging studies. In this session, 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
  • 2 in-depth case studies ― in cardiovascular and pain therapeutic areas
    • 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

And in the second half of the webinar, FDAnews is pleased to present a top expert on model-based drug development, Seth Berry, to walk you through new enhanced drug development methodologies.

Selecting the right dose, population, study, program, and portfolio design are among the most significant challenges facing pharmaceutical companies today. 

In this presentation, you’ll discover how drugmakers can optimize drug development to reduce costs and improve profits … by using sophisticated computer modeling and simulation to identify the most advantageous safety and efficacious dose … design successful clinical trials … create robust clinical development programs … and minimize drug candidate portfolio risks while maximizing return on investment.

Specifically, you’ll find out about:

  • The Model-Based Drug Development Construct
    • Sheiner (Clinical Pharmacology and Therapeutics, 1997)
    • Lalonde, et al (Clinical Pharmacology and Therapeutics, 2007)
  • The benefits of integrating modeling and simulation teams across an organization
  • In-depth Case Studies
    • Case Study 1:  A technique to assist in cohort dose selection based on previous data.
    • Case Study 2:  Evaluating different clinical trial scenarios for optimal safety and efficacy

Get set for 2 ½-hours 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.

This special extended-length webinar is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

And, of course, Ms. Marchenko and Mr. Berry will take your questions. Simply submit them via email, and you’ll have answers by the time the session ends.

Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break your budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

  • 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

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Olga Marchenko is Vice President at Quintiles Inc. 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 i3 Statprobe executive with more than 200 clinical trials under her belt.

Seth Berry is Director of Clinical PK-PD Modeling and Simulation at Quintiles, Inc.  A leading expert working with clients, statisticians, and pharmacometricians in model-based drug development methodologies, he provides strategic leadership and consulting services to clients in data modeling and simulation design to enrich the decision making process.  Dr. Berry has been involved in over 70 modeling and simulation projects in the past decade.

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