Members of the ARLG Multi-Drug Resistant Organism (MDRO) Network coordinating team are visiting sites around the world to assess training success in several regions and find ways to enhance partnerships and practices within the MDRO Network.
This 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.
The MDRO Network has 57 sites in 11 countries. Under the oversight of MDRO Principal Investigator, David van Duin, MD, PhD, and in collaboration with regional leaders Cesar Arias, MD, PhD, David Paterson, MBBS, PhD, Minggui Wang, MD, Lead Clinical Research Associates (LCRAs) David Souto and Beth Evans conducted these site visits in accordance with the National Institutes of Health (NIH) regulatory compliance requirements. Souto traveled to Colombia and Argentina while Evans visited sites in China, Singapore, and Australia.
- Partner with the Regional Coordinator Center (RCC) coordinators to ensure and document that regional oversight is successfully established and fulfill the funding source (NIH) regulatory and quality compliance requirements;
- Determine the need or desire for additional training at the site, Regional Coordinating Center (RCC), or Regional Central Laboratory (RCL) level;
- Ensure that region-specific developed processes and tools meet regional needs and are implemented successfully;
- Ensure that RCCs and RCLs are implementing Good Clinical Practices and Good Documentation Practices successfully;
- Discuss ongoing and future bi-directional collaborations;
- Share lessons learned, discuss efficiencies, and solicit feedback on how ARLG/MDRO can better support our collaborators.
Evans stated, “Being able to connect with these regional centers and sites in person, gives us valuable information and shows us, that despite cultural and language differences, everyone involved contributes their best work to help with combating the global threat of antimicrobial resistance.”
While visiting these RCCs, RCLs, and sites, the ARLG/MDRO team members toured, reviewed, and observed various study related components, facilities, and processes. On occasion, the Lead CRA team member supported the RCC’s onsite efforts, and offered recommendations and re-trainings. These visits highlight the collaborative, bi-directional features of the Network and lay the groundwork for future trials.
MDRO coordinators also hosted regional training sessions during the site visits. These trainings gave members of the ARLG/MDRO coordinating team the opportunity to meet site study teams and other Network members, as well as, provide face-to-face information about study design, procedures, implementation, and clinical research best practices.
“These site visits have given us a great opportunity to get to know the people conducting studies around the world,” said Souto. “Having the opportunity to explain why this work is important and get to know the people at the regional centers has helped us to ensure dedicated engagement, as well as standardization, consistency and quality throughout the MDRO Network.”
