Adaptive designs are a wide umbrella for any design which changes during a trial, but in a pre-specified manner. They may allow for earlier go/no-go decisions and the ability to potentially answer more questions than traditional drug development. For example, testing additional small population subgroups (or tumor types) to be included in a basket trial could result in the approval in any or all groups when those smaller populations may have been excluded in a standard trial. Adaptive designs could include the use of a historical control, borrowing across treatment arms and/or tumor types, adjusting the sample size during the trial, dropping unfavorable arms and/or stopping early due to effectiveness.

Adaptive designs used to have a stigma with some designs, even being considered not “well-understood.” However, regulatory agencies and drug developers are starting to see what fruits these designs may bear, as examples of success include master protocols/platform/umbrella trials, the PREVAIL II Ebola trial and other published studies. These results of interaction with the FDA through the Complex Innovative Design program have become available to the public.

This webinar will provide a deep dive into what questions drug developers can ask themselves to determine whether their development plan is a candidate for incorporating some aspects of an adaptive design and if the plan may be better suited to an early or late phase adaptive design. It will offer an expanded understanding of exactly what it means to run an adaptive trial.

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Speaker

Christopher Tait, PhD, Senior Biostatistician, Synteract

Christopher Tait is a Senior Biostatistician at Synteract, with seven years of experience in analyzing and reporting clinical trial results across all phases of drug development. Dr. Tait has experience in a wide range of therapeutic areas and specializes in adaptive and Bayesian design methodology. He serves as the lead biostatistician on studies and consults with internal team members on running adaptive trials. Dr. Tait holds a doctoral degree in Statistics from the University of Virginia.

Message Presenter

Who Should Attend?

This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

Clinical Affairs
Clinical R&D
Clinical Research
Clinical Pharmacology
Clinical Operations
Project Management
Regulatory Affairs
Medical Affairs

What You Will Learn

Participants will gain insight into:

Addressing key considerations for utilizing an adaptive design
Evaluating how risk profiles can affect adaptive design
Exploring how the FDA’s Complex Innovative Design program is changing the way adaptive designs are viewed

Xtalks Partner

Synteract

With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.