Transforming Concepts Into Clinical Trials and Creating a Multisite Network: The Leadership and Operations Center of the Antibacterial Resistance Leadership Group

Abstract

The Leadership and Operations Center (LOC) is responsible for facilitating, coordinating, and implementing the Antibacterial Resistance Leadership Group (ARLG) scientific agenda by engaging thought leaders; soliciting research proposals; and developing the processes, tools, and infrastructure required to operationalize studies and create and sustain the ARLG network. These efforts are ongoing as new projects are developed and the network expands and grows to address the ever-changing priorities in antibacterial resistance. This article describes the innovations, accomplishments, and opportunities of the LOC since the inception of the ARLG in 2013.

Keywords: antibacterial resistance; clinical trial network; infectious disease; mentoring..

Figure 1.

Antibacterial Resistance Leadership Group (ARLG) protocol concept receipt, review, and approval. Example timelines are shown for PROVIDE (Prospective Validation of the Vancomycin Exposure Profile Associated With Optimal Outcomes Among Patients With MRSA Bloodstream Infections) [2], CREST (Carbapenem-Resistant Enterobacteriaceae in Solid Organ Transplant Patients), and PROOF (Pharmacokinetics, Pharmacodynamics and Safety/ Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adult Participants) [3]. PROVIDE and PROOF concepts were generated by ARLG committees and submitted directly to the ARLG Steering Committee in response to a call for proposals. CREST was submitted via the ARLG website by the CREST investigators.

Figure 2.

Antibacterial Resistance Leadership Group (ARLG) protocol development and study execution. Example timelines are shown for PROVIDE [2], CREST [3], and PROOF [2]. PROVIDE (n = 305) and CREST (n = 170) are noninterventional studies. PROOF is an interventional phase 1 study (n = 19). See Figure 1 legend for study descriptions.