How To Successfully Design and Implement a Clinical Trial To Evaluate the Clinical Impact of New Diagnostic Assays for Testing Positive Blood Culture Bottles

Abstract

New infectious disease diagnostics are being introduced into clinical practice at high rates. For tests that are better, faster, and less expensive than what came before, adoption is easy. However, many new tests, though faster than conventional diagnostics, are more expensive. Whether they will add value to patient care must be evaluated and can best be assessed by randomized controlled clinical trials (RCTs). Here, an overview of RCTs of new blood culture diagnostics is presented. Operational logistics of executing RCTs of new diagnostics are presented based on the authors' experience. For tests that facilitate appropriate use of antibiotics, involvement of an antimicrobial stewardship team in the associated clinical trial is important.