Adaptive Design Trials
Averion has designed and helped launch many Adaptive Design Trials (ADT). ADTs are becoming increasingly popular and have gained acceptance and interest from the FDA, EMEA and other regulatory agencies.
An Adaptive Design Trial uses data that is not available at the start of the study as a basis for the hypothesis and assumption modifications for a trial/program design. For instance, an ADT design can plan for scenarios in order to drop ineffective treatments or incorporate results from other studies not known at study launch. An ADT design can combine Phase II and III programs to save down time between studies. The ADT design is enhanced by more rapid information collection and analysis to adapt to changing outcomes in real-time. The philosophy behind adaptive trial design is to select the most efficient path to approval while maintaining study integrity and validity.
Adaptive Design Trials allow sponsors to make better decisions based on accruing trial data. This allows Sponsors to stop a trial earlier at predefined interim looks, to potentially utilize fewer patients in trials if an advantage is real, to reduce time and costs by eliminating inter-Phase wait times, and to use Phase II results towards the FDA/EMEA submission. Collectively, this strategy can speed timelines, which can lead to earlier product approval or termination routes. The key to performing a successful ADT is proper strategic planning. Averion excel's in these areas by using our statistics to design and analyze the studies and using our processes and systems to collect and adjudicate data. This combination of expert consulting and validated data management services offers viable alternatives to the traditional clinical development paradigm.
Adaptive Design Trial Services include:
- Strategic Trial/Program Planning Using an Adaptive Design
- Simulation Modeling of Scenarios
- Full-Service Management of the Trial
- Rapid Data Capture, Cleaning, and Linkage
- Database Assembly and Adjudication for Data Monitoring Committee Review
- Data Monitoring Committee and Clinical Endpoint Committee Management, Organization, and Support
- Regulatory Guidance and Review with Regulatory Agencies