Identifying and Deploying Benchmarks for Clinical Research at Sites

Clinical trial sites face persistent challenges including inefficiencies in patient recruitment, protocol adherence, and regulatory compliance. To date, standardised benchmarks and supporting tools for site-level evaluation are limited and cumbersome to use.

We carried out a three-phase study comprising of: (1) a scoping review of literature to identify key benchmarks; (2) a Delphi exercise to prioritise these benchmarks; and (3) the development of a tool to identify, and operationalise these benchmarks across diverse clinical research sites, spanning different geographic regions, research settings, and specialties.

Drawing from over 60 sources, 36 performance benchmarks were identified and organised into eight thematic domains. A two-round Delphi process, completed by experts from 9 countries across 4 continents, with experience spanning academia, the pharmaceutical industry, and all stages of the research lifecycle, led to consensus on the relevance and feasibility of adoption. Initial user feedback on the resulting digital tool, which integrates the benchmarks, indicated perceived utility and acceptability, with features such as automated scoring and real-time performance feedback viewed positively by users.

The proposed benchmarking system is intended to support capacity development of trial sites. Designed to be scalable and adaptable, the tool provides a globally translatable framework for assessing and strengthening clinical research capabilities and warrants further real-world evaluation to assess impact on operational and quality outcomes.