Adaptive design is a wide umbrella term for any design that changes during a trial, but in a prespecified manner. This allows for planned modifications to one or more aspects of the design, shifting based on accumulating data, and allowing for earlier go/no-go decisions and the ability to potentially answer more questions than traditional drug development.

Adaptive designs may include:

• Dose finding/trial-arm selection
• Sample size re-estimation
• Treatment allocation/enrichment of patient population
• Stopping early for futility/efficacy
• Endpoint selection

For example, testing additional small population subgroups (or tumor types) to be included into a basket trial could result in approval in any or all groups when those smaller populations may have been excluded in a standard trial.

Regulatory agencies and drug developers are starting to see the benefits of adaptive designs as further examples of successes including master protocols/platform/umbrella trials, the PREVAIL II Ebola trial, and other studies are published.

Synteract’s Christopher Tait, Ph.D., Senior Biostatistician, recently conducted an in-depth webinar on optimizing clinical trials using adaptive design, offering an expanded understanding of exactly what it means to run an adaptive trial, assessing information in master protocols, evaluating the regulatory perspective, and exploring real-world applications in oncology and infectious disease epidemics.

If you missed the webinar live, you can still watch it and learn:

• Key considerations for using an adaptive design
• How risk profiles can affect adaptive design
• How the FDA’s Complex Innovative Design program is changing the way adaptive designs are viewed