How Public–Private Collaborations Are Driving Solutions to the Antibacterial Drug Development Crisis

Leanne Madre, Pamela Tenaerts
2016 Clinical Infectious Diseases  
Keywords. hospital-acquired bacterial pneumonia (HABP); ventilator-associated bacterial pneumonia (VABP); public-private collaborations; antibacterial drug development (ABDD); recommendations. Developing new therapeutic and diagnostic products is difficult. While clinical trials are considered a gold standard within the development process, such trials have become overly complicated, lengthy, and expensive [1] . These problems are more pronounced in certain therapeutic areas, such as the
more » ... such as the development of antibacterial products, and particularly acute in certain diseases and conditions such as clinical trials testing antibacterials to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) [2] . A typical clinical research site in HABP/VABP studies is expected to enroll approximately 1 patient per site per year [3] . In 2012, the US Food and Drug Administration (FDA) Antibacterial Drug Development (ABDD) Task Force asked the Clinical Trials Transformation Initiative (CTTI) to initiate an ABDD program to address issues associated with stalling antibacterial development and a diminishing pipeline. CTTI was asked to focus on optimizing clinical trial feasibility and exploring solutions around clinical trial inefficiencies to facilitate the generation of new antibacterial therapies to treat both general and resistant infections. The purpose of this supplement is to share the work that is being done by CTTI and others to address the urgent need for development of new types of antibiotic drugs. Regulators at the FDA and the European Medicines Agency (EMA) make the case for the value of public-private partnerships to address the challenges of conducting antibacterial trials and the specific role that CTTI has made related to HABP/VABP clinical trials [4] . A goal of this work is that industry will increasingly engage in HABP/VABP clinical research. As multidisciplinary teams were working to identify strategies to streamline HABP/VABP trials, CTTI was also setting up a network of sites ready to participate in the demonstration protocol further outlined in the FDA/ EMA guidance. We are very proud that this supplement makes publicly available recommendations for scientific and operational approaches to streamline HABP/VABP trials. The first set of recommendations focuses on how to streamline the protocol elements, including actionable proposals around early consent and endpoints as well as more general solutions employing Quality by Design principles and the use of central institutional review boards [5] . A second article focuses on recommendations to optimize the operational efficiency of data collection in HABP/
doi:10.1093/cid/ciw314 pmid:27481948 fatcat:fm4lvwj77zckdo2ibvx76g4jmq