Adaptive Trial Design — Is It Right For Your Clinical Study?

Adaptive clinical trials differ from typical trials in their inclusion of pre-planned adaptations to the trial design without the requisite need for a formal protocol amendment. Utilizing the accumulating data throughout the study, alterations may be made to the original methodology, which may include changes to dosage(s) evaluated, patient population, duration based on futility or overwhelming efficacy, and sample size consistent with contemporary regulatory guidance.

Benefits include:

• Potential for lower costs and study efficiencies
• Optimized development program
• Regulatory guidance that enables design, operations, and analyses
• More patients exposed to optimal dose and regimen
• Multi-stakeholder appeal, including patients and physicians