Case Study

Clinical Trial Diagnostic Test Cost Comparison

Source: Blinded Diagnostics

Clinical Trial Description: Warfarin replacement drug study, double-blind, double-dummy. Phase III, Three (3) years to complete.
Number of Sites: 1,500
Number of Participants: 6,000
Diagnostic Test: PT/INR (Prothrombin Test)
Number of Tests: 220,000 (4K participants tested once and 6K participants tested once per month for 3 yrs)

Total Cost Comparison: The actual point of care (POC) costs and proposed central lab costs were compared. The POC costs, including warranty, support and freight, were amortized over the total volume of tests. Total cost for test and materials for POC includes controls, incision device and freight. Total cost for test and materials for Central Lab includes veni-puncture needle, collection tube and shipping box. Total shipping cost of central lab test is based on cost from US collection site to US central lab site.

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