Development of a Composite Site Performance Score: Optimizing Site Selection and Trial Methodology
In this poster you will learn:
- Site performance traditionally has focused on operational metrics, including speed and volume of enrollment. PK data, when available at trial completion, are used as a snapshot of dose adherence.
- Datasets tend to be relatively small and proprietary to a single sponsor or CRO. Different metrics, scoring systems and infrequent updates to the underlying data make it difficult to compare site performance across the industry and to leverage the most up-to-date information.
- The emphasis on enrollment, has, in part, derived from the need to increase patient enrollment in order to account for a possible reduction in treatment effect due to non-adherence.
- More precise measures of participant and site performance collected on electronic platforms offer the opportunity to identify adherence-based variance and other drivers of site performance that can be used to quantify, and benchmark site performance based on a single score, potentially enhancing site selection during the design and execution of clinical trials.
- A Composite Site Performance Score prototype, based on four factors, was developed to quantify and normalize site performance across 52 studies.