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

04/15/2014

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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