Case Study

Objectives

• The Client was active in AMR with extensive global surveillance studies conducted over decades
• Surveillance date usually require the use of a central laboratory for microbiological analysis and reporting.
• Micron were asked to develop a method for accepting anonymised real-world microbiological and outcome data directly from participating RWE study sites, using LIMS (Laboratory Information Management Systems) wherever possible.

Contribution

• Micron enrolled 21 sites in 5 countries (India, Mexico, Saudi Arabia, Spain, UK).
• Microbiological and patient outcome data were collected electronically from site data teams or uploaded manually by the site, depending on capabilities.
• Micron data management services processed and coded all real-world data for 8,060 hospitalised patients, A total of 7,444 records were deemed complete enough for analysis.
• Study results for AMR data were loaded into a custom-built database for the study.
• Study sites and the sponsor can analyse the data via a secure web portal provided by Micron.

Conclusion

This pilot study assessed AMR and patient outcomes using RWE. Sites uploaded anonymised data from electronic health records (EHRs). This method and technology can be applied to other therapeutic areas. A major learning from this study was the nature of data from RWE might be relatively incomplete for some patients compared with clinical trials. Each site is different and a flexible, nimble approach to using EHRs is needed depending upon site capabilities.