Analytical Framework for Examining the Value of Antibacterial Products. 2.1.3 Modifications to the Clinical Trial Process and Approval Standards


This incentive encompasses a number of ideas intended to streamline the clinical trial and drug approval processes for antibacterial drugs in order to shorten the timelines and, in turn, reduce the costs associated with developing these drugs.  Easing the development requirements could reduce development costs by shortening the time to market for these products, thereby increasing the potential returns to developers.

For example, the Limited Population Antibacterial Drug (LPAD) Approval Mechanism proposal put forth by the Infectious Diseases Society of America (IDSA) is one such approach that can be examined in the context of the analytical framework developed.  Under the LPAD proposal, “…the safety and effectiveness [of an antibacterial drug designed to treat serious infections] would be studied in substantially smaller, more rapid, and less expensive clinical trials—much like the Orphan Drug (OD) Program permits for other rare diseases.  LPAD products then would be narrowly indicated for use in small, well-defined populations of patients for whom the drugs’ benefits have been shown to outweigh their risks” (Infectious Diseases Society of America, 2012).

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