Parexel has entered a strategic alliance with Optum, a subsidiary of UnitedHealth Group that sorts, cleans and de-identifies data from electronic health records (EHR) to make it usable in other applications.

With the announcement, Parexel becomes the latest big CRO to ink a deal with an EHR-focused company in order to offer hybrid studies, which combine traditional data collection from patients at sites with data housed in those participants’ EHR.

Last October, Quintiles announced its strategic alliance with IMS Health to offer hybrid studies. A few months prior to that, PPD announced it was teaming up with HealthCore to do the same.

“Hybrid studies are an extraordinary application of data that didn’t exist two years ago,” said Joshua Schultz, corporate vice president and worldwide head of Parexel Access. “The use of electronic medical records can now replace collection of some of the site-inserted data that we typically gather in a normal study. Traditionally, a site might enter 100 pieces of data for a study participant, but in a hybrid study, a lot of that information has already been populated in the patient’s EHR. It can be filtered right into the study data like any other piece of data such as a lab report or an image.”

For those data elements that are critically important, like primary endpoints, and for info that doesn’t fit handily into an EHR field, those conducting hybrid studies continue to use traditional data collection, Schultz added.

Schultz believes it’s the wave of the future, as well as being cost-effective.

“EHR data is much less expensive to collect, and the site-based data provides you with high quality and high consistency that’s hard to get from an electronic medical record (EMR),” he said. “But together, the two can generate savings of 20% plus on the cost of a trial.”

Companies like Optum work to sort and clean data from EHRs. In regard to health economics, said companies are connected to large payers who have data on the cost benefit of treatments. This data can be incorporated into previously gathered trial information.

Schultz explained that, with the economic data at hand, those conducting a study can include claims information and can examine the cost of treatment and follow-up care alongside the cost of the innovation they’re working on. This, said Shultz, provides useful health economics data to offer payers when a drug goes to market and is coming to be known as “real-world data.”

To be sure, hybrid studies have their limits, said Nancy Dreyer, global chief of scientific affairs and senior vice president of real-world and late phase research at Quintiles.

For one, there’s the problem of harmonizing. According to Dreyer, there are currently some EHRs with reams of robust data that are standardized and quite usable for research. Take the Kaiser system, with its thousands of doctors using one system in a standardized way. But what if a CRO is using the system as well as several other systems for a hybrid trial? How can one be sure the data coming from one is as clean, robust, readable and standardized as coming from another? Also, if a CRO only uses one system—for example Kaiser’s—will their study unwittingly reflect the way medicine is practiced there? And if so, are the results of the study generalizable?

“These are matters that are still being worked out about hybrid studies,” said Dreyer.

There’s also the matter of how doctors interact with EHR systems. For instance, one physician may pull incoming lab reports into a patient’s larger record, while another might leave incoming lab reports in a more secondary place. Leaving them in such a place is problematic because they may never get integrated into the person’s record and may never be used for research.

Dreyer pointed out the EHR can’t always account for patient behavior. It might show whether a prescription was written, but not whether the person ever filled it. That’s where the addition of claims data can offer a more complete picture.

These issues are being worked out in phase IV post-approval studies, as CROs look to harness this concept to improve data quality, decrease cost and appeal to payers when it’s time to take a drug or device to market.

Are hybrid studies poised to take off and revolutionize the way clinical research is conducted? Schultz is inclined to think so.

“Like reduced site data verification, a lot of innovations that matured in late phase and beyond were applied to earlier phases,” Schultz said. “My expectation is that this will probably follow a similar path.” 

Suz Redfearn is an award-winning journalist and former senior staff writer for ClinPage.com. Her articles have appeared in numerous publications, including the Atlantic.com, the Washington Post, Slate, Salon, Politico, Men's Health, MedPage Today and Physicians Practice. Suz holds a degree in print journalism from Loyola University in New Orleans and has been a medical writer since 1990, focusing on clinical research since 2007. Email suzredfearn@gmail.com.

This article was reprinted from Volume 20, Issue 05, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »