I recently had the opportunity to talk with Allison Proffitt, Editorial Director of Clinical Research News, about EHR to EDC integration.
To write that I enjoyed our interview is an understatement. Her questions revealed her depth of knowledge about the clinical research industry and her insight into the challenges those of us who work in this industry routinely face.
I was particularly gratified at her statement at the end of our interview,
It sounds like you have really put a lot of thought into developing something that’s going to make the clinical research worker’s life better and also really improve the trials that we’re able to do and the data we’re able to deliver in the industry.
Proffitt’s first question was:
With so much patient data in silos, how can clinical trial sites and study teams get a big picture view of their participants?
My answer:
Historically, it has been an incredibly manual process to collate, collect and abstract clinical trial data from multiple places in the healthcare environment. As Proffitt knows well, it’s incredibly inefficient to transcribe and abstract data manually from the EHR into electronic case report forms (eCRF) for research.
New tools such as OpenClinica Unite™ and new capabilities enabling the extraction of data from the electronic health record (EHR) offer a real opportunity to streamline the traditional process, achieve higher levels of quality, and obtain new types of data that previously were impractical to get – and that in turn, can open up new science. We are able to automatically acquire data in a validated manner, which saves labor and time, ensures a much higher level of quality and reduces clinical monitoring and data reviews.
EHR to EDC Integration Improves the Work and Job Satisfaction of Clinical Research Staff
Proffitt also asked whether OpenClinica Unite can improve the work and job satisfaction of clinical research staff. In response, I discussed the ‘swivel chair model for data entry,’ which has clinical research coordinators using two screens, two URLs and two patient IDs while they swivel back and forth and feed data from the EHR to the research database. Instead, OpenClinica Unite requires one click to launch the participant’s eCRF right out of their patient chart in the EHR and is a single sign on. The system is able to bring the researcher directly to the target record in the research system and then we can pull over and pre-populate eCRFs data from the EHR – and subsequently eliminates time consuming and error prone manual clinical trial data entry
Proffitt followed up with a question about how much effort it takes to go from the traditional system of two screens to EHR to EDC integration. In short, there is no software to install and no servers to run locally. We have developed a technology model that is easy for sites to adopt and sponsors to use in multi-site trials in a repeatable way with all of the configurability needed for different trial designs. Our use of open standards and security protocols ensures a high level of confidence in the integration.
Proffitt also wanted to know how much training is required for workers to which I replied, “It’s less training than would be necessary for accessing the EDC in the more traditional standalone manner.” We have streamlined the implementation process and are now able to complete the installation in a couple of weeks at each site.
During the interview, we also touched on decentralized clinical trials. We agreed that there are a range of different trials that can be labeled as decentralized and therefore a need for clinical trial solutions to be flexible, as OpenClinica’s tools are.
To listen to the full interview, visit: https://www.youtube.com/watch?v=bVgivrMICiM