EHRs and Clinical Trials

Last month I wrote a story for KM World magazine that looked at many aspects of the clinical trials process that automation, integration and knowledge management solutions might be able to improve. Since then, I have seen several references to other efforts to bolster clinical trials.

A June 16 story in Modern Healthcare describes how a consortium of academic medical centers, pharmaceutical companies and other healthcare-related organizations has created an initiative to design clinical-trial-recruitment data sets that could be incorporated into electronic medical-record software.

According to the article, the Partnership to Advance Clinical electronic Research 's current participants include Strong Memorial Hospital of the University of Rochester (N.Y.); North Shore-Long Island Jewish Health System, Great Neck, N.Y.; drugmakers Pfizer, Johnson & Johnson and Merck & Co.; the bioethics research group the Hastings Center; and the Healthcare Association of New York State, a statewide hospital association.

It's becoming clear that as more medical centers develop sophisticated EHRs and data warehouses, they are seeing the potential to mine those records for possible trial participants, and several groups are working on moving data between EHRs and electronic data capture systems used to capture trials data.

One example I found for the KM World story involves Mayo Clinic in Minnesota. It has spent five years building a data warehouse called the Enterprise Data Trust (EDT), which includes information on more than 7 million patients. Mayo has teamed with startup company Centerphase Solutions to review study protocols and identify Mayo patients who potentially qualify for enrollment in a specific clinical trial.

I also found that since much of the data that clinical trial managers need is already being gathered for clinical purposes and entered into EHRs, some research organizations have been working on greater interoperability between the EHR and the electronic data capture (EDC) system used to record data for the clinical trial.

CDISC, a nonprofit group in Texas that develops standards for clinical research data exchange, has done several pilot projects, including one with Eli Lilly and EHR vendor Cerner to retrieve data for an EDC from within the EHR system.

"We have had good success with that approach, pre-populating a case report form from within the EHR, with 30 percent to 80 percent of the data elements needed, which saves time and energy," said Landen Bain, healthcare liaison to CDISC. "Instead of seeing the EHR as just a bucketful of data, we see it instead as an application that provides business process automation."

To read the whole story, go here: www.kmworld.com/Articles/Editorial/Feature/KM-bolsters-clinical-trials-67327.aspx