Background
For decades, global antimicrobial resistance (AMR) surveillance has relied on central laboratories to collect and analyse microbiological data. While these studies provide essential insight into resistance trends, they often lack the real-world patient context — how infections are managed, what outcomes occur, and which factors influence recovery.
To close this gap, the sponsor sought to test a new model: integrating microbiology data with real-world clinical and outcome information drawn directly from hospitals across multiple regions. The result was CODAR — the Comprehensive Online Database for Antimicrobial Resistance, a pilot Real-World Evidence (RWE) initiative designed to merge laboratory precision with everyday patient data.
The Challenge
Unlike traditional surveillance, CODAR required data to be captured not from a single central lab but from multiple hospital systems, each with different infrastructures, record formats, and digital capabilities.
Some sites maintained robust electronic health records (EHRs) and Laboratory Information Management Systems (LIMS), while others relied partly on manual data entry. The challenge was to create a harmonised, quality-controlled dataset that reflected real-world complexity without compromising accuracy, anonymity, or data security.
Micron’s Contribution
Micron was tasked with developing and operationalising the data infrastructure and oversight model for this first-of-its-kind RWE AMR study.
Our team enrolled 21 hospital sites across five countries — India, Mexico, Saudi Arabia, Spain, and the United Kingdom. Working closely with each institution’s data teams, we established data-transfer pipelines to receive anonymised patient-level information covering both microbiology and clinical outcomes.
Depending on each site’s digital maturity, data were either uploaded directly from EHR/LIMS systems or submitted manually through secure Micron portals. Once received, our Data Management specialists coded and processed the full dataset of 8,060 hospitalised patients, reviewing and cleaning records to ensure completeness and consistency.
Of these, 7,444 patient records (92.4%) met the inclusion criteria and were retained for analysis — a major achievement given the scale and heterogeneity of data sources.
Micron then developed a custom-built online database and web portal through which the sponsor and participating sites could view, query, and analyse aggregated AMR and outcome data securely.
The Result
The CODAR pilot successfully demonstrated that real-world hospital data could be integrated with microbiological results to generate a richer understanding of AMR and its clinical implications. It marked a shift from laboratory-only surveillance toward outcome-linked resistance intelligence — bridging epidemiology, microbiology, and clinical medicine.
Outcome and Impact
CODAR proved that real-world data (RWD) collection is possible at scale, even across sites with different technical capacities. The study revealed key lessons for future RWE programmes:
Flexibility is essential. Each hospital’s systems and workflows are unique; data solutions must adapt to local capability.
EHRs hold immense potential. With the right validation and coding frameworks, they can become powerful tools for clinical research.
Cross-country harmonisation is achievable. Standardisation and secure digital infrastructure can align global contributors under a single analytical environment.
Micron’s technology and coordination expertise enabled CODAR to bridge the gap between controlled trial data and real-world clinical outcomes — laying the foundation for broader application of this model in other therapeutic areas beyond infectious disease.
"Team members are fully engaged and take responsibility for the studies as if they were their own."
Project Manager