Thought Leadership

The ARLG brings together the world's top investigators in antibacterial resistance to collaborate in a dynamic, innovative environment. ARLG leadership includes an executive committee and two principal investigators: Vance Fowler, MD, MHS, Duke University, who focuses primarily on operations and Henry "Chip" Chambers, MD, UCSF, who concentrates on the scientific agenda. The ARLG includes four component centers, which together provide the critical infrastructure and operational expertise required for a successful clinical research program.

Vance Fowler, MD, MHS

Henry “Chip” Chambers, MD

Scientific Leadership Center

The Scientific Leadership Center (SLC) is co-directed by the two ARLG principal investigators: Henry "Chip" Chambers, MD, UCSF, and Vance Fowler, MD, MHS, Duke University. The SLC organizes multiple scientific committees, chaired by internationally recognized leaders in the field, to foster collaboration and connectivity with antibacterial researchers around the world. The purpose of the scientific committees are to review proposals, assign scientific merit scores, and prioritize the scientific agenda. The SLC engages thought leaders and solicits research proposals.

Clinical Operations Center

Heather Cross, DPhil

The Clinical Operations Center (COC) is under the direction of Heather Cross, DPhil, Duke University. Housed at the Duke Clinical Research Institute, the COC is responsible for facilitating, coordinating, and implementing the ARLG scientific agenda. The COC develops site networks, processes, tools, and infrastructure required to operationalize studies. The COC created and sustains the ARLG Infectious Disease and Multi Drug Resistant Organism site networks. These are large networks of experienced clinical trial sites with appropriate patient populations to address resistance pathogens in multiple disease states in both inpatient and outpatient settings. Currently, the COC coordinates more than 40 studies at 130 research sites with collaborations in 19 countries.

Statistical and Data Management Center

Scott Evans, PhD

The Statistical and Data Management Center (SDMC) is under the direction of by Scott Evans, PhD, George Washington University. The SDMC provides the ARLG with statistical and data management expertise to advance the network's scientific agenda. The SDMC is active at all stages of a study, including design, data collection and monitoring, data analyses and archival, and publication of study results. The SDMC enhances the scientific integrity of ARLG studies by developing and implementing innovative and practical statistical methodologies, educating colleagues on clinical research fundamentals, and providing resources to the research community. The SDMC has developed multiple methodologies such as the Desirability of Outcome Rankings (DOOR) and Partial Credit. These two novel methods of analysis classify patients according to their overall clinical outcomes taking into account benefits and harms using ordinal categories.

Laboratory Center

 

Robin Patel, MD

The ARLG Laboratory Center director is Robin Patel, MD, Mayo Clinic, with Ephraim Tsalik, MD, PhD, Duke University Medical Center serving as the associate director. The ARLG Laboratory Consortium Team includes Robert Bonomo, MD, Case Western Reserve University; Barry Kreiswirth, PhD, Rutgers University; Cesar Arias, MD, PhD., University of Texas Health Science Center; Thomas Lodise, PharmD, PhD, Albany College of Pharmacy and Health Sciences; Kimberly Hanson, MD, University of Utah; and Melinda Pettigrew, PhD, Yale University.

The Laboratory Center leads the evaluation, development, and implementation of laboratory-based research by providing scientific leadership and supporting specialized laboratory services. The Center conducts laboratory-based studies using the Master Protocol for Evaluating Multiple Infection Diagnostics (MASTERMIND) initiative for researching multiple diagnostic devices from a single patient sample. In addition, the Center supports a robust Virtual Biorepository with consultation services on the selection of strains for research purposes.

Publications

The ARLG is committed to sharing research findings to inform practice guidelines that improve patient care. View our publications.

Scientific Assets

Research Agenda

The ARLG scientific agenda prioritizes three areas of research and solicits proposals for clinical research studies focused on 1) infections caused by Gram-negative bacteria; 2) infections caused by Gram-positive bacteria; 3) diagnostics.

MDRO Network

The Multi-Drug Resistant Organism (MDRO) Network is a global community of professionals with a common mission to participate in clinical trials that: 1) provide observational data to aid in the design of randomized clinical trials on therapeutics and diagnostics for MDRO infections; 2) develop new diagnostic and treatment paradigms; and 3) inform clinical practice that will improve the care and outcomes of patients with antimicrobial resistance around the world.

MASTERMIND Protocol

MASTERMIND (MASTER protocol for evaluating Multiple INfection Diagnostics) is a statistical concept developed by the ARLG that is based on the premise that one single participant can provide information and samples for the simultaneous evaluation of multiple diagnostics. Using the MASTERMIND protocol, multiple companies are able to submit a 510(K) under one protocol. In addition, clinical trial researchers have the capacity to evaluate multiple diagnostic tests at the same time, realize efficiencies of specimen collection and characterization, and overcome monetary and logistical hurdles associated with new diagnostics.