Site and Country Selection Optimer

Site selection is one of the most challenging problems in clinical trial planning.

Site Selection Optimizer

Poor site selection may cause significant enrollment delays, waste money on zero enrollers, and compromise trial results. At the same time, site selection should meet many contradictory requirements, such as recruiting targets, budgeting constraints, business rules, and many others.

The site selection process includes two steps.

1. Site feasibility

Questionnaires, analysis of various databases, and subjective assessments are used to get a set of feasible sites. AI is also used to enhance a preliminary set of sites. For example, 200 sites were pre-selected, but only about 50 sites were needed for a clinical trial. How to do it?

2. Site selection

Three approaches could be used

Subjective site picking
Ranking algorithm. All feasible sites are divided into three tears. The first tear represents the "best" sites. The second tear represents the intermediate sites, and the third is the worst sites. Sites are ranked according to their value. Site selection starts with the best sites from the first tear, then – the second and third tears.
The optimized site selection.

ORBee Consulting proposes an optimization model (Site Optimizer) which guarantees optimal site selection. The model selects an optimal set of sites and simultaneously aligns the budget (investigational payments), recruitment target, site capacity, and trial power. The model can be used for strategic (before the trial starts) and operational planning (after the trial – replacement of zero enrollers, recruitment target corrections, etc.)

Which approach generates the best solution?

The optimization algorithm found a better solution than the one based on the ranking. It automatically selects a portfolio of sites aligned with study goals and resources. At the same time, to reach study goals, the ranking algorithm requires ~12% bigger budget and more sites (17 – ranking vs. 16 – optimization).

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