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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
PubMed

Insights

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.

Keywords:
Clinical trialsPediatric Diabetes ConsortiumPediatric type 2 diabetesT2DM

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