Linking clinical data from electronic health records (EHRs) to clinical trial and other research data captured by electronic data capture (EDC) systems is a hot topic in both the pharmaceutical and health care industries. Considerable progress toward achieving paperless research data collection has occurred, but interoperability hurdles, uneven EHR adoption, and a host of other issues have slowed efforts to link EHRs and EDC systems.
Still, most observers say the collision between these platforms is inevitable, providing opportunities and challenges. Anthony Costello, cofounder and VP of Nextrials, a San Francisco electronic data capture company developing Web-based software for clinical trials management, spoke with Digital HealthCare & Productivity about melding EHR and EDC systems. Costello is also chairman for the Society for Clinical Data Management (SCDM).
DHP: Much of the data needed for clinical trials is already captured in the hospital’s EHR. Getting the data directly from the hospital’s database has many obvious benefits. Why has the industry been so slow to implement this process?
Costello: The pharmaceutical industry has been slower to adopt eClinical systems than many of us thought they would be. But we are now just seeing the real hockey stick part of the curve for EDC adoption, and we’re even earlier in the process for EHR adoption. Only 15-20 percent of hospitals use EHR systems, and only 40-50 percent of pharma companies use EDC; so it’s early on the adoption curve for both these technologies. Moving forward, it’s going to become more obvious that these systems should be talking to each other.
I expect the emergence of standards that we’ve seen in the last few years will drive adoption in the next few years. It used to be that proprietary software interfaced these two systems because the industry’s regulatory agencies had such a high bar for patient and data security and validation. But when CDISC (Clinical Data Interchange Standards Consortium) showed up a few years ago, a lot of that custom software went away as the system on one end spits out a standard XML file in the CDISC format, and the system on the other hand knows how to read that file. This makes things much easier.
DHP: What is the role of EDC in using EHRs for clinical trials?
Costello: At the most basic level, one would interface EHR with EDC just to pull the pharma relevant data out of the EHR system. I think anyone who can interface EHR with EDC has as one of their primary goals that they’re going to auto-populate case report forms (CRF) and save clinical trial site nurses and doctors from having to re-enter that data into a pharma system.
But from there, there are a million directions as to where it can go. It’s estimated that 80 percent of all clinical trials experience recruitment delays. This can translate to site and sponsor frustration and add millions of dollars to the cost of developing a new drug. We’re working actively to be able to use EHR system data as a patient recruitment tool: a way of finding patients who match certain protocol criteria. EHR systems can provide medical history and demographic data that you need to randomize patients.
Obviously EHR systems can be trolled for all sorts of critical information to understand the safety profile of a drug or patient population. They can be used longitudinally for large numbers of patients over time, which we’re hoping can replace some early phase clinical trials. You might not even need to run a Phase I study [in some cases] if you can look at historical data for that patient population. EHR systems make this easier.
This is just the beginning. Fast forward 10 years, when every person has their entire medical history in a database; then the computer can do a more interesting job of mining that data for useful trends and information.
DHP: What are the challenges in tapping EHRs for clinical trials?
Costello: A lot of the challenges we’ve seen for the last 8-10 years have been overcome and now we’re looking at new challenges. There has been an evolution. When we first started doing this in the late ’90s, no one used computer systems at all. Then there were all sorts of privacy and HIPAA concerns. And everyone started using the Internet, and there were worries about Internet security.
Now we’re past a lot of this and have a new set of challenges. It’s not good enough to ask the doctor to use this EDC, EHR, or lab system — we actually want all these systems integrated with one Web interface and one login. So the challenge has become the integration of these systems and the standards to tie all these disparate systems together with some universal standard that makes sense.
Another challenge is to stay current, because Web development technologies are changing so fast that the kind of stuff we were building two years ago with HTML just looks ancient today. Some of the newer Web technology, like Java, Ajax, and Flex provides a much faster experience for the user, sending much smaller tidbits of data over the Internet — it’s a much sexier, user-friendly kind of interface, and in another two years it will change again. So the challenge, from a development standpoint, is less about convincing everyone that the data is safe and more about keeping your product line integrated and as current as possible.
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