25 January 2023
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Antimicrobial resistance (AMR) has been recognized as a persistent and urgent global issue. An analysis conducted in 2019 showed that almost 5 million deaths were associated with infections caused by drug-resistant bacteria.1 This has led to common infections that could previously be easily treated becoming more dangerous.2 The growing urgency precipitated a Wellcome Trust investment in 2021 in a platform to warehouse antimicrobial susceptibility data generated by the pharmaceutical industry. Vivli, a nonprofit entity dedicated to advancing human health through data sharing,3 was contracted to launch the platform. Vivli supports data contributors and requesters through governance, technology and streamlined processes and acts as a trusted, neutral entity to balance the interests of both data contributors and requesters. Subsequently, the AMR Register, a web-based platform that provides free access to susceptibility data, was launched for anyone interested in AMR.
Pharmaceutical surveillance data
Antimicrobial susceptibility surveillance programs conducted by industry are mandatory and comply with regulatory agency (FDA and EMA) requirements for commercial approval of new antimicrobial agents. In addition, post-approval surveillance must be conducted over a period of years as an essential tool to monitor the development of resistance to a new agent. These industry datasets are typically generated by a central laboratory that uses CLSI and EUCAST adherent reference methods.4,5 In addition to the new antimicrobial, numerous comparators are tested, resulting in a robust picture of the state of AMR. These datasets are often multi-national and include additional information regarding specimen sources and collection methods. Some sponsors make these data available through their sponsor websites – for example, the Pfizer-ATLAS and Merck-SMART platforms offer sophisticated visual heatmap displays and tabular reports. Sponsors usually publish data from these endeavours, but the scope of the data is summarized and often narrowly focused on the drug of interest.6-9
Antimicrobial stewardship relies on understanding AMR trends and having access to relevant susceptibility data for a given location or country so that informed decisions can be made for prescribing appropriate antibiotics, which will aid in the fight against AMR.
Accessing biopharmaceutical surveillance data through the AMR Register
In June 2022, Vivli launched the AMR Register. The purpose of this register is to implement a unified platform where public health bodies, researchers and healthcare professionals can navigate, search, request and access high-quality industry antimicrobial susceptibility surveillance data for individual clinical isolates for further analysis. The data hosted in the register consists of raw minimum inhibitory concentration (MIC) data from pathogen susceptibility studies. For each of these datasets, aerobic, anaerobic, mycobacterial or fungal pathogens (one isolate per patient) were obtained from clinical sites around the world. The isolates are accompanied by some basic demographic information, including age, gender, country, hospital ward (including outpatient), specimen source and length of hospital stay to determine nosocomial or community-acquired infections. Researchers may undertake projects including the detection of trends in multi-drug resistance over time, informing national and international policy and advancement of antibiotic stewardship, and modelling future resistance trends. For example, extracting data for a particular pathogen or country of interest is possible.
Researchers can now request high-quality biopharmaceutical surveillance data from AMR Register Steering Committee companies with major antimicrobial programs, including Pfizer-ATLAS, Merck-SMART, GSK-SOAR, Johnson and Johnson-DREAM, Paratek-KEYSTONE, Shionogi-SIDERO-WT and the Venatorx-Global Surveillance program.
Figure 1: Attributes of datasets available in the AMR Register
The ecosystem of AMR platforms
The AMR Register complements existing efforts that support the antimicrobial community8 such as the UK Antimicrobial Register (UKAR)9 developed to capture real-world usage of antimicrobial agents, the World Health Organization’s (WHO) Global Antimicrobial Resistance and Use Surveillance System (GLASS)10 that issues yearly reports and the European Centre for Disease Prevention and Control’s European Antimicrobial Resistance Surveillance Network (EARS-Net) 11,12 that contains a high-level presentation of resistance trends. The AMR Register hosted by Vivli differs from these efforts in that raw data at the MIC level are made available to researchers.
“As one of the authors of the ‘Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis’ [report], I recognize how critical it is to access data on the prevalence of resistance for pathogen-drug combinations as well as on the distribution of pathogens by infectious syndrome. Improving the availability of and access to AMR data is a public health priority that the AMR Register is poised to address.”
Andy Stergachis, University of Washington
Impact and call to action
Our aim is to make the AMR Register data as widely available as possible to researchers and policymakers, as a universally free and easily searchable platform for public access is a significant step towards advancing antibiotic stewardship. Researchers have already begun to access these data, and we call on other entities who may be interested in stepping forward to contribute or access data to explore this valuable resource. Antimicrobial stewardship relies on understanding AMR trends and having access to relevant susceptibility data for a given location or country so that informed decisions can be made for prescribing appropriate antibiotics, which will aid in the fight against AMR.
References
- Murray CJ, Ikuta KS, Sharara F, Swetschinski L, Aguilar GR, Gray A et al. (2022) Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. 399(10325):629-655.
- Centers for Disease Control and Prevention (2013) Antibiotic resistance threats in the United States, 2013.
- Li R, Scott J, Rockhold F, Hill N, Wood J, Sim I (2018 ) Moving Data Sharing Forward: The Launch of the Vivli Platform. NAM Perspectives. 8(11).
- CLSI (2022) M07: Dilution AST for Aerobically Grown Bacteria. Clinical & Laboratory Standards Institute.
- EUCAST (2022) AST of bacteria.
- Johnson A, Enne V, Perry J. (2018) Preface. Journal of Antimicrobial Chemotherapy. 73(suppl_5):v1-v1.
- Karlowsky J, Lob S, DeRyke C, Hilbert D, Wong M, Young K et al. (2022) In Vitro Activity of Ceftolozane-Tazobactam, Imipenem-Relebactam, Ceftazidime-Avibactam, and Comparators against Pseudomonas aeruginosa Isolates Collected in United States Hospitals According to Results from the SMART Surveillance Program, 2018 to 2020. Antimicrobial Agents and Chemotherapy. 66(5).
- Rossolini G, Stone G, Kantecki M, Arhin F. (2022) In vitro activity of aztreonam/avibactam against isolates of Enterobacterales collected globally from ATLAS in 2019. Journal of Global Antimicrobial Resistance. 30:214-221.7.
- British Society for Antimicrobial Chemotherapy (2022) UK Antimicrobial Registry
- World Health Organization (2021) Global antimicrobial resistance and use surveillance system (GLASS) report
- Rossolini G, Bochenska M, Fumagalli L, Dowzicky M (2021). Trends of major antimicrobial resistance phenotypes in enterobacterales and gram-negative non-fermenters from ATLAS and EARS-net surveillance systems: Italian vs. European and global data, 2008-2018. Diagnostic Microbiology and Infectious Disease4: 115512.
- Ashley E, Recht J, Chua A, Dance D, Dhorda M et al. (2018) An inventory of supranational antimicrobial resistance surveillance networks involving low- and middle-income countries since 2000. Journal of Antimicrobial Chemotherapy. 73(7):1737-1749.
Rebecca Li is the Executive Director of Vivli and on faculty at the Center for Bioethics at the Harvard Medical School. Previous to her current role, she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital at Harvard for over five years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process, with experience in biotech, pharma, and CRO environments. She completed a fellowship in 2013 in the Division of Medical Ethics at Harvard Medical School. She earned her PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.
Patricia A. Bradford is the owner of Antimicrobial Development Specialists LLC, a consulting company that focuses on the late-stage development of antibiotics. Before this, she was responsible for microbiology support contributing to the successful development and approval of ceftazidime-avibactam at AstraZeneca. Patricia also worked in antibiotic research for Novartis, Wyeth Pharmaceuticals and Lederle Laboratories. During her tenure at Wyeth, she worked on a number of antibiotic projects and was instrumental in the team that wrote the dossier for the registration and approval of tigecycline. She was also heavily involved in the studies of several NDA applications for piperacillin-tazobactam.
Patricia is a fellow in the American Academy of Microbiology and a senior editor for ASM’s newest journal, mSphere. She is also an active member of the subcommittee on Antimicrobial Susceptibility Testing of the Clinical Laboratory Standards Institute and served as an editor for Antimicrobial Agents Chemotherapy from 2001-2011.
The authors declare that they do not have any relationships or affiliations that could be construed as a potential conflict of interest.
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