The FDA recently released new guidance on using electronic health record (EHR) data in drug and biologic clinical trials. This 35-page document is timely because there is now more EHR data available than ever before.
This abundance of healthcare data holds great promise for streamlining clinical research and one of the first areas of promise is the opportunity it provides for researchers to efficiently find patients for studies, regardless of the study protocol.
Using EHR Data for Trial Enrollment Isn’t as Simple as It Seems
While the vast amount of EHR data now available promises greater efficiencies, using EHR data for trial enrollment is not as simple as typing trial criteria into a search bar and having the right match pop up.
EHR data comes from many different sources, and in different formats with varying degrees of quality. The data is also collected by a range of organizations and is therefore stored in a variety of locations and networks. If a researcher wants to use EHR data to fill their study, they need to go across several data partners to collect the data, sift through the numerous types of data — each with varying amounts of information — and then find a way to search that collection in a way that’s consistent with their given protocol. This is the problem of “interoperability” which has existed ever since we sought to use healthcare data for clinical research.
Only Elligo Health Research® has the largest known patient network, offering direct access to more than 150 million patients through HIPAA-compliant identified EHR data. Elligo also works with different partners to find patients across disparate data systems, creating a one-stop shop for accelerating and elevating clinical trial enrollment.
Where Are the Patients?
There’s a wealth of EHR data available today, but what’s needed is an organization that knows how to work with the data and the organizations housing that data to provide an answer to the most common clinical trial question: Where are the patients?
Using a combination of its internal EHR network, external data partners, analytical expertise, and years of experience, Elligo searches across a vast number of patients to find those needed for any given trial, allowing recruitment to proceed at pace.
Almost any organization can do a quick search and tell a researcher, for example, the state of New York has 600 diabetic patients fitting the criteria for their study. Elligo can not only search the entire country for patients who fit a specific need but can also find patients who are already known to sites and/or physicians and quickly enroll them in a trial. Elligo takes a patient search from an overall heat map down to Fred sitting in the easy chair in his living room or, in other words, from numbers to known patients.
Direct Access to Data and Patients… Only Elligo
Only Elligo can bring together disparate EHR data sources and glean effective, useful information from them to place patients in a specific clinical trial, shorten study startup, and deliver faster treatments for the patients who need them.
Contact Elligo today to learn how our access to EHR data can accelerate and improve clinical trial enrollment.