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Transforming Performance of Clinical Trials in Pediatric Type 2 Diabetes: A Consortium Model
Michelle Van Name1, Georgeanna Klingensmith2, Bryce Nelson3
1Department of Pediatrics, Yale University, New Haven, Connecticut.
Diabetes Technology & Therapeutics
|December 21, 2019
Summary
The Pediatric Diabetes Consortium (PDC) model enhances clinical trial efficiency for youth type 2 diabetes drugs. This collaborative approach streamlines protocols and oversight, aiding successful drug development.
Area of Science:
- Pediatric Endocrinology
- Clinical Trial Management
- Diabetes Research
Background:
- Completing Phase 3 clinical trials for pediatric type 2 diabetes is complex.
- The Pediatric Diabetes Consortium (PDC) was established to address these challenges.
Purpose of the Study:
- To describe the PDC Consortium model designed to improve the efficiency of pediatric diabetes clinical trials.
- To highlight the model's role in facilitating the completion of critical drug trials.
Main Methods:
- Development of a Coordinating Center and Executive Committee to centralize oversight.
- Implementation of a Consulting Group for protocol design optimization.
- Establishment of Master Service Agreements and standard Site Budgets.
- Regular conference calls for sponsor/CRO interaction and performance monitoring.
Main Results:
- The PDC model was instrumental in completing the pivotal liraglutide trial for youth type 2 diabetes.
- PDC centers exceeded enrollment targets in two ongoing diabetes studies.
- The model has successfully launched new type 2 diabetes studies.
Conclusions:
- The PDC Consortium model demonstrates effectiveness in improving pediatric clinical trial efficiency.
- Ongoing efforts aim to expand the model's application to type 1 diabetes and other related studies.
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