Site Effectiveness Index: A strategically important metric in clinical trial planning

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The importance of site activation planning and implementation is a given among those who develop and manage clinical trials. However, some key considerations are often overlooked in the planning process, such as: How should we measure site activation? What is a good site activation plan? How do we define the relationship between site activation and other variables in clinical trial planning and execution?

To address these and related questions, in 2008 Phesi developed and patented its Site Effectiveness Index (SEI), which defines utilization of enrollment capacity within a group of investigator sites allocated to one clinical trial. For example, for a trial with 50 investigator sites and a 12-month enrollment cycle time (i.e., elapsed time from first to last enrolled patient), activating all 50 sites on the first day of the trial would yield an SEI of 100%. On the flip side, if we activated all 50 sites on the last day of the 12-month period, the SEI for this trial would be 0.

A more realistic scenario emerges from Phesi’s analysis of 2,145 clinical trials sponsored by the 15 global pharmaceutical companies that conduct the largest number of trials; each trial utilizes 30 to 60 investigator sites. The following chart shows a blinded SEI ranking of these 15 companies:

Interestingly, the median SEI for the top 15 pharma is 60%, lower than the industry median, which is consistent with other metrics we analyzed.

The strategic importance of the SEI lies in its potential for optimizing site activation. Simply put, a higher SEI percentage can translate into a shortened enrollment cycle time and/or a lesser number of investigator sites needed for a trial, in a fairly linear fashion.

One distinct feature of Phesi’s clinical development platform is our integrated approach to assessing variables that impact clinical trial planning and implementation. That approach allows us to define quantitative relationships among key variables such as investigator site performance, business processes (especially site activation), and protocol design.

Armed with insightful analysis of those variables, we can help our clients manage potentially difficult issues such as CRO selection and oversight, protocol design and optimization, forecasting clinical trial outputs and deliverables, and developing performance benchmarks. In short, our platform can remove much of the ambiguity surrounding clinical development, thereby making the process more manageable and with a much higher chance of successful outcomes.

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