KM bolsters clinical trials

Information gathering and recruitment for clinical trials haven’t shown much technological progress, according to Greenspun. “It is better in oncology, but for a kid with asthma or a person with depression, the traditional way they find out about clinical trials is pretty primitive compared to the possibility that their physician might see a pop-up on their screen about potential trials for them to learn about. So the EHR can facilitate that,” he says.

EHRs can also be valuable for follow-up and surveillance. “If there is an adverse event outbreak with a pharmaceutical, figuring out whom to contact can be difficult,” Greenspun says. “It is easier to recall a car. But with widespread EHRs, it will be much easier to identify the person with congestive heart failure on a certain drug. That is a great use of data mining.”

Finding prospects quickly

One physician group that has been actively involved in clinical trials for years is the Holston Medical Group in Tennessee. Dr. Jerry Miller, president and founder of the group, credits its Allscripts TouchWorks EHR with helping to identify and track patients.

The multispecialty group has conducted more than 1,400 clinical research studies for pharmaceutical companies such as Merck, Hoffman LaRoche, Pfizer and GlaxoSmithKline.

“We have 108 ongoing studies and 17 new ones in the works,” Miller says. “We have 700 patients enrolled in clinical trials.”

When a medical device maker or pharmaceutical company approaches Holston with a study proposal, the medical group can quickly sort through its 287,000 patient records to determine if it can populate the study. “Within an hour we can see if we have 50 patients who meet a certain criteria for a diabetes study, for instance,” Miller says. “You can’t do that with paper charts.”

Once a patient is entered into a trial, the physician or nurse practitioner will see an icon in their medical record noting that they are in a clinical trial. “That catches their eye,” Miller explains. “They can click on it and read about the trial and make sure they are not violating protocols.”

The business side of managing clinical trials

Historically the software automation focus of clinical trials management has been on the collection of subject data through electronic data capture. But a clinical trial is also a business project, so there have been efforts to help automate the business processes as well.

Bob Webber is VP of clinical trial management systems with BioClinica, which recently purchased Webber’s previous company, TranSenda International. One challenge clinical trial management software has faced, Webber explains, is interconnecting with all the other systems, including EDC, involved in tracking a study. “It is a challenge getting timely access to operational data,” he says.

TranSenda developed a system based on Microsoft SharePoint technology that involves using Web services to allow workers to access study information from within Microsoft desktop products such as Outlook calendars and Excel spreadsheets.

One organization taking advantage of that integration is the Harvard Clinical Research Institute (HCRI) in Boston, an academic research organization established by the Harvard Medical School, Beth Israel Deaconess Medical Center and Partners HealthCare. It has worked with TranSenda to simplify its existing systems to manage and monitor the documents related to clinical trials.

“We have worked with HCRI to create role-based portals,” Webber says, “so that project managers and site monitors can more easily get the information that they need to do their jobs.”

Other types of integration work between EHR software and clinical study management software are underway. StudyManager, whose software is designed to help evaluate a clinical research site’s productivity, has developed a solution in collaboration with EHR vendor Allscripts so that all the patient information is available in one place.

“A big component of what a clinical trials manager is looking at is the patient database to search who in a population might fit a certain criteria,” says Alec Fishburne, VP of operations for StudyManager. “This used to involve double entry of data or worrying if the two databases were synced.”

Now all demographic information on study participants can automatically flow from Allscripts into StudyManager, and having an interface between the two databases simplifies the process of screening candidates.

The automation of clinical research steps and the use of EHRs to help identify and track trial participants have the potential to spur dramatic improvements in drug development, safety and efficacy.

“This is the brave new world of personalized medicine, where in oncology, for instance, you only get the treatment if you have the right biomarker,” Dell Perot’s Greenspun says. “You use data mining to identify which patients are most likely to respond to a certain therapy. That is going to be the future.” 

From EHR to EDC

Since much of the data that clinical trial managers need is already being gathered for clinical purposes and entered into electronic health records (EHR), 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 (lilly.com) and EHR software 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,” says 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.”

Although it makes sense to work on interoperability because they are collecting a lot of the same information, EHRs and EDCs are designed quite differently to meet different purposes. “EHRs are maintained for a longitudinal look at someone’s health,” says Judy Hanover of IDC Health Insights. “Trial software is to track someone over a short, set number of visits, and the software is hard-wired to facilitate that. There are FDA rules about collection and validation, and checks on the software development process.” Bain says the goal is not to have the EHR replace the EDC, but just to create some efficiencies rather than having siloed systems that can’t talk to each other.