My objective was to play counterpoint to the recent LinkedIn blog by Michael Crayne, titled: Why we can't integrate EMR and EDC and to provoke additional dialogue around this vital topic. However, I just learned the heartbreaking news that Michael passed away last week. So, I hereby dedicate this blog to his wisdom and service to our industry – with appreciation to Michael Crayne for provoking thoughtful debate and dialog, while expanding our collective wisdom.
I wanted to weigh in on the topic, given my background, of the evolving state of the life sciences industry, and the provocative title of Michael’s blog. Full disclosure: Yes, I work for one of those electronic data capture (EDC) vendors (OmniComm Systems) that claims: “We can integrate with EMR/EHR.” And yes, I am proud to be doing much of the “claiming.”
Nearly 20 years ago, in 1998, I was overseeing the clinical technology practice for FCG, and we were contracted by a then-leading electronic medical/health records (EMR/EHR) vendor to map the typical data collected in an EMR system, with the data captured in a standard clinical data management (pre-EDC) application. The objective was to integrate EMR/EHR with a clinical data management application and with the vision that all clinical trials data would eventually be harvested from existing EMR/EHR applications. We learned, at the time, that a good percentage of typical safety domain data (demographics, medical history, medications, indications and adverse events), along with the majority of lab results, could be delivered through EMR technology. The gap, of course, was in the therapeutic-specific efficacy data, which varies widely from trial to trial and therapy to therapy.
Fast forward 18 years, and not a lot has changed. Most clinical data is still entered redundantly in two separate systems; integration efforts are still very isolated, and the standards for integration have not been widely adopted. Thus, it would be simple to deduce that we just can’t integrate EMR and EDC.
But, wait! In reality, a great deal has changed over the past 18 years. We are on the forefront of massive transformation in the way healthcare and life sciences co-exist and collaborate, and an even greater revolution in the way that clinical data is collected and used.
So, with that said here is my top-10 list:
The value proposition is too great to ignore – better, cleaner, faster data; reduced costs of data review, monitoring and source data verification; improved efficiencies of safety surveillance, site payments and study closeout activities. Oh, and how about this one: What is the value of increased site satisfaction?
The 2013 FDA Guidance on Electronic Source Data in Clinical Investigations and the 2016 Draft Guidance on the Use of EHR Data in Clinical Investigations are designed to pave the way for this pending paradigm shift. The MHRA also recently issued a similar positional statement and guidance.
Beyond clinical trials, there are countless other commercial and scientific consumers of EMR/EHR data, including payers, providers, pharmacogenomics, pharmacovigilance, pharmacoeconomics, etc. So, integration is happening, regardless of whether we leverage the EMR/EHR data for clinical trials.
Granted, there is still a large gap between health data standards (HL7, SNOMED, LOINC, ICD10, etc.) and clinical research data standards (CDISC, MedDRA, WHODRUG, e2B, etc.). But the industries are beginning to play together and new standards, such as Fast Healthcare Interoperability Resource (FHIR), are being piloted by both the EHR and EDC communities. The common adoption of these new standards could be the missing link that gets us to the finish line.
Our industry is going through a generational change with the rapid adoption of mobile, wearable and cloud-based technologies, along with more robust integration and authentication mechanisms. Integration attributes and eSource capabilities that were considered innovative or future state are now considered essential elements or common practice.
The life sciences community has come to recognize the importance of clinical research investigator sites as paramount to patient recruitment, patient retention, clinical insight, medical leadership and future drug prescriptions. There’s greater incentive today, more than ever before, for these entities to work as collaborators.
Life sciences and healthcare communities are now very focused on improving the patient experience. With all sorts of patient-enabling technologies and apps, certainly a single source of data for the clinical trial patient is one of the low hanging fruits to increase patient confidence in our technology and processes.
Academic medical and research centers that are typically strapped for funding and research grants now understand the commercial value of running a well-managed clinical trials center. There has been a great deal of recent investments in technology, compliance, people and processes. The value proposition of integration for these clinical sites is possibly greater than the value to the sponsor based on potential time and cost savings, quality improvements, risk reduction and the recognition that comes along with technology leadership.
At OmniComm Systems, we have multiple ongoing clinical trials receiving data from an EMR/EHR system and using several different integration channels. In one case, 100% of the study data is entered through the EHR, and the EDC application is used for data cleaning, coding, interim analysis, review, signing and locking – along with all the downstream activities, such as reporting, archiving and creation of SDTM and analysis datasets. We also have initiatives ongoing with multiple EMR/EHR vendors to leverage industry standards to push data out from EMR/EHR to EDC. Patient privacy is foremost in each of these activities, and the data must be anonymized prior to leaving the EHR premises.
It’s been nearly 50 years since we landed a man on the moon – I’m not saying EMR-to-EDC integration is easy, but we’ve come of age – the time to make this happen is now.
Bottom line – I agree it’s not easy, and it must be secure; and certainly, patient privacy is foremost. But the value proposition is too great. It’s time for all parties to join in, and let’s make this thing happen! Please let us know what strides your organization has made in this area.
I wish Michael was here to respond, but I’m sure he would appreciate knowing that his article has sparked ongoing discussion.
About the Author: Ken Light
Ken Light has spent nearly thirty years delivering technology implementation, integration, process improvement, and business strategy services to the global Life Sciences community, focused on technology to support clinical research. For the past ten years, Ken has built and grown OmniComm’s professional services organization, and now oversees corporate strategy for OmniComm Systems.
Prior to joining OmniComm Systems, Ken oversaw similar clinical strategy and technology consulting practices for Oracle Corporation, BusinessEdge Solutions, and First Consulting Group. Ken has worked with the majority of top twenty pharmaceutical manufacturers, along with many academic, research, and life sciences organizations. Ken is a subject matter expert and frequent presenter at industry conferences related to clinical trial technologies, standards, and strategy.
Mr. Light has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.