Like other sponsors, Novartis told Outsourcing-Pharma, it has long been looking at ways to obtain data directly from the electronic health record (EHR) directly into the research databases hosted in an electronic data capture (EDC) system.
With Clinical Pipe, Protocol First offers an application that promises real-time transfer of data from EHR into EDC. Novartis is putting the application through testing and, while still in the proof-of-concept phase, Aafter testing the waters, Novartis reports is positive and optimistic about the application.
During the recent SCOPE 2020 conference in Orlando, FL, Craig Serra, global head of strategy and innovation for data operations at a Novartis, representative highlighted ongoing work including a proof-of-concept (PoC) with the Clinical Pipe product.
The program connects EHR-to-EDC using substitutable medical applications and reusable technologies (SMART) and Fast Health Interoperability Resources (FHIR) standards to transfer data from system to system, often referred to as “SMART on FHIR.”
Serra of Novartis told SCOPE attendees, with the disclaimer that he was only expressing his own opinion and not the official position of Novartis, “In over 18 years, I have never seen such enthusiasm and green-lit, thumbs-up, across-the-board enthusiasm for an idea.”
“To be successful we need buy in from data operations, but also from CRAs, trial managers, and regulatory experts. Most critically, we will need partnership from study coordinators and investigators at sites,” Serra related.
Serra told us he is leading an initiative to evaluate how Clinical Pipe works, and how it impacts data operations, clinical monitoring, data review, organizational and regulatory aspects, change management needs, and more.
“We will use these learnings to frame a pilot program that includes active investigator sites who use Clinical Pipe currently,” he told us. “We can then look at comparing sites in the same study not using Clinical Pipe and determine the impact on some pre-determined key performance indicators.”
The next step after the initial PoC and pilot, Serra said, is reviewing output in 2020, refining the scaling strategy the team set out, then continuing its “test, learn, apply, and repeat” process.
“We have to look at the output from the PoC and pilot and examine indicators of value and impact. We have a scaling strategy if there is evidence to do that, but like any experiment, we will let the data and results guide the way,” he said.
Hugh P. Levaux, Ph.D., Protocol First founder and CEO, told us the disconnect in information sharing stems from the divergent evolution of related but different fields—namely, healthcare and clinical research.
“This is the story of so many industries, not just clinical research. About 20 years ago, healthcare invested in EHR, while pharma invested in EDC,” he said. “Since then, they’ve grown in completely separate directions and adopted different standards.”
William Aldridge, Head of Sales for Protocol First, told Outsourcing-Pharma much time is wasted by nurses, clinical trial coordinators and other site staff having to re-enter and check data.
“These people have to do what’s known as ‘the swivel chair,’” he said. "They enter information into the EHR, and then they have to switch over and transcribe it into the EDC.”
Aldridge said the turnaround time is typically two weeks, but the process can take much longer, depending on a variety of factors. Clinical Pipe can transfer data the same day.
According to Protocol First, the Clinical Pipe platform reduces unnecessary work performed by site staff. For example, Aldridge said, “Oregon Health and Science University, said that an average patient visit went from 45 minutes to 5 minutes, freeing trial personnel up for more important work besides data entry and verification.”
“We’re giving them back 1-3 hours of their day,” Aldridge said. “The feel-good factor is patients get better care—they get more face time with providers. Sponsors get cleaner data, faster, and they save on onsite monitoring because they have to perform fewer visits per year. Literally, everyone wins”
Additionally, Duke reported an error rate of about 9 percent when manually transferring EHR information into an EDC. No such errors when transferred via the validated application, Clinical Pipe.