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Collaborative Staffing Model for Multiple Sites: Reducing the challenges of study coordination in complex, multi-site

Mary E Larkin¹, Paul McGuigan², Denise Richards³

¹TODAY Study Diabetes Educator Committee.

Applied Clinical Trials

|June 24, 2014

Summary

A unique staffing model for the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study improved complex clinical trial management. This collaborative approach between program coordinators and diabetes educators enhanced flexibility and reduced staff burden.

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Area of Science:

Clinical Trials
Endocrinology
Pediatrics

Background:

Complex, multi-site clinical trials face significant challenges in recruitment, participant follow-up, and staff organization.
The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study, sponsored by the National Institutes of Health (NIH), addresses type 2 diabetes in youth.

Purpose of the Study:

To describe a unique collaborative staffing model involving program coordinators (PCs) and diabetes educators (DEs) in the TODAY study.
To evaluate the impact of this model on managing challenges in complex clinical trial implementation.

Main Methods:

A self-administered survey was distributed to PCs and DEs across all study sites.
The survey assessed the degree of overlap and task sharing between PCs and DEs.
Specific examples of collaborative problem-solving were collected.

Main Results:

The collaborative model demonstrated significant task sharing and overlap between PCs and DEs.
This approach provided mutual support, decreasing the burden typically placed on a single PC.
Flexibility and cross-coverage were enhanced through this staffing structure.

Conclusions:

The PC-DE collaborative staffing model is effective for managing complex, multi-site clinical trials.
This model enhances operational efficiency and staff support in pediatric diabetes research.
Mutual support and task sharing are key to successful clinical trial implementation.