Improved efficiency while moving through the clinic.
Improve Clinical Trial Efficiency
Adaptive design has gained momentum over the past decade. Cited by the FDA’s Critical Path Initiative (CPI) as a method to improve trial efficiency, adaptive clinical trial designs are proven methods with a wide range of benefits. WCCT and Medelis provide multiple adaptive design options to reduce your costs and increase efficiencies in the clinic.
By using accumulating trial data and sophisticated simulations, you can utilize a “flexible adaptive design” to gain an understanding of how to change specific aspects of your study, while still maintaining its integrity and validity.
Adaptive designs can give you:
- Faster go/no-go decisions
- Risk mitigation
- Increased safety by stopping ineffective or unsafe drugs
- The ability to more quickly determine the optimal dose and frequency
- Reduced costs due to fewer patients
- Reduced time to market from combining proof-of-concept trials with dose-finding trials, or by combining dose-finding trials with confirmatory trials
A Variety of Adaptive Design Options
WCCT and Medelis can work with your team to create a variety of different adaptive designs:
- Adaptive randomization design
- Adaptive seamless Phase II/III design
- Group sequential design
- Drop-the-loser design
- Multiple adaptive design
- Adaptive dose-finding design
- Biomarker-adaptive design
- Adaptive treatment-switching design
- Hypothesis-adaptive design
Our regulatory team is actively involved in each adaptive clinical trial design to ensure that the level of adaption is acceptable to the relevant regulatory agencies, to confirm the regulatory standards for data review and approval, and to determine if the study has met the original study objectives.
We offer the expertise, software and global footprint to make your adaptive clinical trial a success.