FDA Compliancy for Adaptive Trial Implementation
A major concern among many drug companies is that precious patient resources on therapies and doses are potentially wasted and are unlikely to be successful. Adaptive designs are created to prevent waste, speed up drug development and increase accuracy in identifying the appropriate dose, regimen and indication.
The adaptive approach also allows for addressing questions that could never be addressed in a balanced randomised trial. Individual questions such as discriminating the effect of one dose from that of another dose may not have high power, but some power may be better than none.
As a leader in the adaptive revolution, the FDA recently issued a draft guidance for industries regarding the use of adaptive designs in the regulatory setting, focusing principally on “adequate and well controlled” phase III trials.1
Furthermore, the FDA’s Critical Path Initiative encourages the use of (i) innovative clinical trial design and (ii) biomarkers in the early phases of drug development. 2
Adaptive design differs from a traditional design in that it uses accumulating results in the trial to modify the trial’s course. All adaptations should be completely specified in advance of the trial, at the design stage, so that operating characteristics can be calculated.
In this webinar, participants will learn:
- Using a Bayesian approach for developing adaptive designs
- Practical examples of designing and conducting clinical trials using adaptive designs for regulatory approval.
- The benefits and challenges of adaptive designs
- The limitations and disadvantages of adaptive designs
- The implications of the FDA Guidance on late phase adaptive trials
- Adaptive designs in early phase trials
- Adaptive designs in pivotal Phase 3 studies
1. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf
2. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm
Presenters:
Donald Berry, Ph.D
Head of the Division of Quantitative Sciences, Chair, Department of Biostatistics
M.D. Anderson Cancer Center
