HCLS/ClinicalObservationsInteroperability/PatientRecruitment

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High Level Use Case for Clinical Trial Patient Recruitment

A clinical researcher wants to commence patient recruitment for a clinical trial. A nurse is allocated to the job of finding potential candidates. He/she is sent into the filing room(s) where 3 months or more is spent going through patient files. After that time the nurse returns with potential candidates for the trial. After that comes the filtering and final selection. The time and effort spent manually searching through patient files is largely wasted, given that most if not all of the information exists in various Electronic Patient Records (EPR).

This seemingly simple use case is a vital one for those wishing to carry out clinical trials, be they trials carried out at the request of pharmaceutical companies, or individual clinical trials driven from a research perspective. A scalable, repeatable, robust solution here will not alone reduce the time taken in patient recruitment, but also in the management of the clinical trials and subsequent follow-up with the patient.

What solutions have been implemented here have been based on largely manual software development efforts, where bi-directional interfaces are written for every EPR system within the "feeder environment" (e.g. hospital). This effort will work for that individual hospital, but the same effort will have to be undertaken in the next hospital/clinical research centre combination, and so on – a lot of work which could be avoided if a solution can be provided.