CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Dr. Martin Gibson, chief executive of the U.K.’s NorthWest EHealth, which develops links between academia and the U.K.’s National Health System in health informatics and the use of electronic patient records to support research. Dr. Gibson helped develop the Salford Lung Studies, two recent GSK-sponsored trials that substituted EHR for regular patient visits.
Q: Five years ago, you spearheaded what you called the “first real-world, large-scale pragmatic randomized clinical trial,” the Salford Lung Study. What did that look like, and how did it go?
A: The studies—there have been two of them, one in COPD and one in asthma, both in conjunction with GSK—have gone really well. But it’s not so much what we found as the way we found it. These were late-phase studies that used eHealth records to monitor patients in real time. Consented participants had only two in-person visits—one at the beginning and one at the 12-month point at the end of the study. There were no required visits in between, which was very unusual as researchers often see patients every three months or so in order to satisfy regulatory requirements. In the Salford Lung Study, any time the participant was seen within the NHS anywhere in the U.K., we got an alert saying, ‘This person is having an event,’ and we were able to capture all the data from their visit, whether they were seeing a doctor or going to the hospital. If they were admitted to the hospital, we could track their progress there. We could see the results of blood tests, we could look at their EKG, X-rays and so on.
Our studies had to comply with all the same regulatory standards as a regular phase III study, but we got far more detail about participants’ overall health picture than you ever would over the course of a traditional clinical trial. Regulators picked up on that. Of course, some participants didn’t see a doctor at all during the 12 months of the studies, and those patients got a phone call from us every four months saying, ‘Are you ok?’ We did very few of those. These participants—who all had lung issues—were seeing their healthcare practitioners on a regular basis, so it worked well.
Q: Did the logistics of it all play out the way you’d hoped? Could the Salford Lung Studies change the way clinical trials are run worldwide going forward?
A: Eventually the logistics worked out, but first we had to build all the links. We had 88 general practitioners, multiple hospitals and out-of-hours services. To keep things ‘real-world,’ study drugs had to be picked up from local retail pharmacies, so we had to get all the pharmacies—144 separate retail pharmacies, from single operators to big chains—up to speed and linked. Now that it is done, we have created a system we can re-use, and that’s what we’re planning to do.
This really does change the way clinical trials are done. For both trials, a total of 7,200 patients were followed in close to real time with EHRs, drawn from a population catchment area of about 600,000. To get those numbers for a phase III trial, you would normally have to go across the world using multiple study sites, which involves a lot of logistics and cost. With a trial like ours, you lose all that cost as you capture everything electronically and in one geographic location.
During recruitment, we found that quite a few patients who had previously opted out of sharing EHRs opted back in once we explained how exactly we’d use it and how it could benefit both them and future patients.
We are now confident we could do the same thing anywhere in the U.K. We really think what we accomplished is a game changer.
Q: Could this work outside the U.K. in areas that are not linked together via a common health system?
A: There are some difficulties, as data is more siloed where there isn’t a national health system, but it’s not impossible. This works best where it’s possible to pull the data from a whole community of care. There are places around the U.S. that have communities of care. I think this is going to happen elsewhere, and it will completely change the way we do clinical trials, making them less expensive and faster.
I know the FDA is now looking at how EHR information could be used to support regulatory approvals. Here in the U.K., we’re looking at earlier phase studies as the near real-time safety monitoring systems give us confidence this will be possible.
We’re also extending our capabilities into after-market studies as well as data to support accelerated access review. If adopted widely, these technologies could be a big win for everybody.
This article was reprinted from Volume 21, Issue 09, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »