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Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study
Kimberly Spencer1, Kelly Colvin, Brad Braunecker
1Lilly Diabetes, Eli Lilly and Company, Indianapolis, IN 46285, USA. spencer_ka@lilly.com
Journal of Diabetes Science and Technology
|January 9, 2013
Summary
Implementing a seamless phase 2/3 clinical trial for diabetes therapeutics requires significant upfront planning and cross-functional coordination. Operational challenges, including infrastructure flexibility and drug supply management, were addressed for successful trial execution.
Area of Science:
- Clinical trial design
- Pharmacology
- Diabetes therapeutics
Background:
- Adaptive trial designs offer efficiency but pose unique operational challenges.
- Seamless phase 2/3 trials integrate dose-finding and efficacy assessments.
- Diabetes therapeutics development requires robust trial methodologies.
Purpose of the Study:
- To detail the operational challenges encountered during the planning and implementation of an adaptive, dose-finding, seamless phase 2/3 trial for a diabetes therapeutic.
- To discuss resolutions for key operational hurdles in adaptive seamless trial designs.
Main Methods:
- Comparison of adaptive seamless design with conventional trial designs.
- Focus on upfront planning, cross-functional integration, and infrastructure adaptability.
- Emphasis on rapid data acquisition, analysis, and reporting for adaptive algorithms.
- Management of drug supply across multiple international sites for nine treatment arms.
Main Results:
- Significant upfront planning and enhanced cross-functional coordination were necessary.
- Existing infrastructure required modifications for flexibility to accommodate the adaptive design.
- Rapid data processes were critical for the adaptive algorithm's success.
- Complex drug supply logistics were managed across global sites.
Conclusions:
- Adaptive, seamless trial designs necessitate a proactive approach to operational planning.
- Flexibility in infrastructure and efficient data management are crucial for successful implementation.
- Careful management of drug supply is vital for multi-arm, global trials.
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