Identifying and Deploying Benchmarks for Clinical Research at Sites.

Area of Science:

• Clinical research operations
• Health services research
• Biomedical informatics

Background:

• Clinical trial sites face ongoing issues with patient recruitment, protocol adherence, and regulatory compliance.
• Current methods for evaluating clinical trial site performance are often standardized, cumbersome, and lack adequate supporting tools.

Purpose of the Study:

• To develop a standardized, adaptable, and globally applicable benchmarking system for clinical trial sites.
• To create a digital tool that operationalizes identified benchmarks for diverse research settings.

Main Methods:

• A three-phase study involving a scoping review of literature, a Delphi exercise with international experts, and the development of a digital tool.
• Identification of 36 performance benchmarks from over 60 sources, organized into eight domains.
• Consensus building through a two-round Delphi process involving experts from 9 countries across 4 continents.

Main Results:

• 36 key performance benchmarks were identified and validated by international experts.
• A digital tool integrating these benchmarks was developed, receiving positive initial user feedback for its utility and features like automated scoring.
• The tool demonstrated perceived utility and acceptability, with features such as automated scoring and real-time performance feedback being positively received.

Conclusions:

• The developed benchmarking system offers a scalable and adaptable framework to support the capacity development of clinical trial sites globally.
• The tool aims to enhance the assessment and strengthening of clinical research capabilities worldwide.
• Further real-world evaluation is recommended to confirm the impact of this system on operational and quality outcomes in clinical trials.