Analytical Framework for Examining the Value of Antibacterial Products. 5.1.3 Clinical Research Costs


Depending upon the characteristics of the diagnostic, manufacturers might be required to perform one or more clinical trials, to obtain data for a 510(k) and data to obtain a CLIA Waiver for POC use.  While only a small fraction of 510(k) devices perform any clinical trials, most of the FDA-approved rapid diagnostics for bacterial diseases have conducted clinical trials in support of their 510(k) applications.  Thus, we assume that the manufacturer of a new MRSA rapid POC diagnostic will need to conduct a pivotal clinical trial to demonstrate substantial equivalence to a predicate device.  Based on discussions with industry experts and ERG’s research, the pivotal trial costs could range from a low of $250,000 to as high as $4.0 million for some diagnostics that require 3,000 – 4,000 patients and collection of multiple specimens and inclusion of symptomatic as well as asymptomatic patients.  Given the wide range, we use a point estimate of $2.0 million for conducting pivotal trials for a rapid POC diagnostic for MRSA.  It should be noted that the estimate may overstate the clinical research costs given information provided in some of the recent 510(k) submissions for a MRSA rapid POC diagnostic test (U.S. Food and Drug Administration, 2007).  Similar to the other parameters, we assume that the clinical research costs follow a triangular distribution with a lower bound of $250,000 and an upper bound of $4.0 million.

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