Objective Internal Monitoring Can Improve Trial Conduct, Results

Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.

Objective internal monitoring can help clinical trial sponsors transform a regulatory mandate into a valuable quality improvement tool. International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and national regulatory bodies such as the Food and Drug Administration, the European Medicines Agency and Health Canada already require sponsors to monitor studies in order to ensure patient safety and data quality. Meeting those regulatory requirements with a robust and objective monitoring systems helps sponsors identify program-specific challenges and design mitigation measures that improve trial quality.

“Monitoring generally results in findings,” said Susan Devine, Senior Manager, Clinical Trials Support Unit, The Hospital for Sick Children, Toronto, Canada. “For example, clinical research in pediatric cancer is conducted in the real life clinical setting, therefore there are few reviews that will not result in deficiencies. An effective monitoring plan acts as the catalyst for change by identifying deficient areas.”

Ms. Devine was lead author on an article describing ways plan sponsors can adapt mandatory monitoring requirements to improve internal trial processes and results. An objective monitoring approach includes four key elements.

• A standard operating procedure outlines the monitoring plan, expectations, and the proposed action plan to ensure impartiality.

• A monitoring template with a yes/no response and opportunity for comments ensures objectivity and a consistent approach across the research enterprise.

• A cyclical monitoring model produces findings that lead to quality improvement plans with  subsequent monitoring to ensure the effectiveness of action plans and identify new deficiencies.

• A well-documented information dissemination plan ensures that appropriate staff and trial personnel are cognisant of problem areas and that potential improvements are discussed in a multi-disciplinary environment.

“An effective monitoring plan acts to continuously raise the bar of research excellence,” she said. “Objective internal monitoring allows a program to identify deficiencies, recognize opportunities for improvement, and measure success.”