Access Planning and Resource Coordination for Clinical Research Operations.

Area of Science:

• Operations Engineering
• Clinical Research Management
• Health Informatics

Background:

• Clinical research sites face complex operational planning challenges due to time-sensitive, resource-specific trial protocols.
• Current site planning and participant scheduling methods result in long, variable wait times (Time to First Available Visit - TFAV) and high staff overtime costs.

Purpose of the Study:

• To develop an operations engineering and management methodology to optimize clinical trial site planning and coordination.
• To introduce a decision support tool, CAPTAIN, for selecting valuable research trials and planning participant bookings within resource constraints.

Main Methods:

• Developed CAPTAIN, integrating participant trajectory forecasting with an efficient visit booking reservation plan.
• Utilized a Mixed Integer Program to estimate site metrics, optimizing daily nursing staff schedules alongside participant visit bookings.
• Incorporated constraints such as staff overtime costs and TFAV by trial.

Main Results:

• CAPTAIN provides decision support for optimizing the selection of research trials based on available resources.
• The method generates a plan for booking participants' first visits, aiming to minimize TFAV and/or staff overtime.
• Optimized daily nursing staff schedules are created to align with participant needs and resource availability.

Conclusions:

• The CAPTAIN methodology offers a novel approach to enhance operational efficiency in clinical research settings.
• This tool can help research sites better manage complex scheduling, reduce participant wait times, and control operational costs.