Bolstering the complex study start-up process at NCI cancer centers using technology.

Area of Science:

• Clinical Trials
• Regulatory Affairs
• Health Informatics

Background:

• The study startup process for interventional clinical trials is complex and team-dependent.
• Decentralized processes can lead to delays in study approval and impact patient safety.
• Optimizing startup is crucial for efficient clinical trial progression.

Purpose of the Study:

• To highlight a developed platform for streamlining the clinical trial study startup process.
• To improve transparency and tracking within the study startup workflow.
• To facilitate collaboration between regulatory management, site development, cancer center administration, and Biostatistics & Informatics Shared Resources (BISR) teams.

Main Methods:

• Development of a centralized platform integrating multiple teams' checklists.
• Clear articulation of review guidelines for Disease Working Group (DWG), Executive Resourcing Committee (ERC), and Protocol Review and Monitoring Committee (PRMC).
• Implementation of a system to track each step and its history throughout the review process.

Main Results:

• Well-defined processes and tracking methodologies enable close study monitoring.
• Operations teams can dynamically prioritize work and meet 90-day and 120-day deadlines.
• Principal investigators gain a transparent view of study status, allowing for proactive preparation.

Conclusions:

• The implemented process and technology significantly expedite reviews and minimize startup delays.
• Opportunities exist for further refinement, such as automating deadline notifications.
• Continuous improvement of the study startup process is essential for efficient clinical research.