What can we learn with Real World Data?

Insights that accelerate timelines for patients in need

BY Michelle Hoiseth, Chief Data Officer, Parexel - 9.18.19 -

What if you could shorten enrollment timelines in rare disease clinical trials, not by enrolling patients in the study’s control arm, but by using data already stored in healthcare electronic medical record (EMR) systems to create a synthetic control arm? Can we quantify the value of reduced timelines, saving patients from unnecessary treatments, and getting new medicines into the hands of patients sooner?  

Today, Parexel is tackling this challenge. Our teams are directly sourcing EMR data from three partner data sources in the US, as well as collecting these data in a traditional Electronic Data Capture (EDC)-based system from dozens of sites in Spain, Italy and France.  By aggregating these data sources into a single data reservoir, we can then render them into a common data model.  We’re then able to match the patient profiles of those enrolled in the study’s investigative arm using approximately six to eight attributes and transform these data into the study’s comparative cohort. 

The learnings from this process are critical, ranging from informing validation requirements of the EMR sources, timing, statistical analysis plan development, how EMR data structures influence EDC design and standard process requirements, and cost drivers. If the sponsor plans to use the study for subsequent regulatory filings, the Parexel team performs audits and mock regulatory inspections to ensure the study has the required data integrity

This is just the tip of the iceberg of and truly multi-functional approach led by Parexel’s diverse clinical and regulatory expertise.  Leveraging innovations like this one, Parexel is helping our customers bring impactful, new therapies to patients around the world in faster and more efficient ways.


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