Protocol feasibility workflow using an automated multi-country patient cohort system.

Area of Science:

• Biomedical Informatics
• Clinical Trial Management
• Health Data Science

Background:

• Clinical trial design and execution face inefficiencies in patient recruitment.
• Current protocol feasibility assessments are often manual and time-consuming.
• Integrating electronic health records can improve clinical trial processes.

Purpose of the Study:

• To present the development of the Electronic Health Record for Clinical Research (EHR4CR) platform.
• To describe the automated multi-country patient cohort system within EHR4CR.
• To evaluate the impact of EHR4CR on the protocol feasibility process.

Main Methods:

• Development of a technological platform integrating electronic health records for research.
• Implementation of a system for defining and applying patient inclusion/exclusion criteria.
• Deployment of an automated, multi-country patient cohort identification capability.

Main Results:

• The EHR4CR system facilitates the creation of specific patient cohorts across international sites.
• Automated patient identification based on complex criteria is now feasible.
• The study reflects substantial changes in the protocol feasibility workflow.

Conclusions:

• The EHR4CR platform offers a significant advancement in clinical trial design and execution.
• The automated multi-country patient cohort system streamlines protocol feasibility.
• This technological solution has the potential to accelerate global clinical research.