Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note...

Area of Science:

• Oncology
• Clinical Trial Management
• Rehabilitation Medicine

Background:

• Data and Safety Monitoring is crucial for clinical trial quality assurance.
• Non-regulated trials often lack mandated monitoring, leading to underutilization and underreporting.
• The Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial is a non-regulated study for cancer survivors.

Purpose of the Study:

• To outline the development and implementation of a bespoke Clinical Monitoring Strategy for the ReStOre II Trial.
• To provide a template for establishing monitoring strategies in non-regulated clinical trials.
• To enhance quality assurance and governance in non-regulated cancer rehabilitation trials.

Main Methods:

• Development of a comprehensive trial governance structure, including a Trial Management Group, Trial Steering Committee, and Independent Data Monitoring Committee.
• Implementation of external trial monitoring by a Clinical Research Facility.
• Conducting three key monitoring visits: site initiation, interim, and close-out.

Main Results:

• The Clinical Monitoring Strategy for the ReStOre II Trial has been finalized and is currently being implemented.
• Two site initiation visits and one interim monitoring visit have been successfully completed.
• The strategy establishes a robust governance framework and external monitoring for a non-regulated trial.

Conclusions:

• The developed Clinical Monitoring Strategy is effective for implementation in non-regulated clinical trials.
• This research provides a practical template for other non-regulated trials seeking to enhance monitoring and quality assurance.
• The strategy supports the successful execution of the ReStOre II Trial, aiming to improve rehabilitation for cancer survivors.