Industry’s Response to the Pandemic Has Accelerated Shift to More Patient-Centric Approaches
The COVID-19 pandemic has changed so many things about our personal and work lives that have us anxious to get back to normal. The pandemic has also led to some significant changes in clinical trials – welcome changes that Oracle Health Sciences believes are likely to become the norm for future trials.
Former Oracle Health Sciences general manager Steve Rosenberg talked about these changes as part of a discussion on clinical trial technology in a recent EDC Clinical Leader Live event. In working with so many companies who are using Oracle Clinical One for COVID-19 related studies, Rosenberg has seen the impact of COVID-19 on trials firsthand. In many cases, companies have stopped enrolling people in existing trials or delayed new trials because COVID-19 precludes a lot of in-person clinic visits.
At the same time, some companies have designed trial protocols to reduce or even eliminate the need for patients to visit trial sites. Instead, they’re setting up “decentralized” trials that rely on home visits, telemedicine, and the ability of new technology platforms to capture and manage data from sensors, patient-worn devices, and other remote sources.
In business, virtual meetings and Zoom conferences have become such a way of life that we no longer see the need to get on a plane just to attend a meeting. Similarly, it’s unlikely that trials will revert back to the older forms, either. This is really a major shift toward trials becoming more patient-centric, and it’s a welcome and necessary shift, said Rosenberg.
Consider that the biggest factor delaying clinical trials today – made even worse by COVID-19 – is enrollment. It’s just plain difficult to find enough patients to participate in trials, in large part because the way many trials are designed is extremely inconvenient for patients. At a conference a few years ago discussing oncology trials, the number one barrier to participation cited by participants was a lack of parking at test sites, Rosenberg recalled. Who would have thought?
Nobody wants to circle around finding a parking spot so they can spend three or four or even eight hours at a clinic. So the ability to do home health, virtual visits and telemedicine are key to making trials more convenient for patients, which lessens the enrollment barrier. The current environment has helped push the industry from looking at decentralized trials as a series of pilots to accelerating adoption because they are simply better for patients.
Companies also need to look at the technology they are using to support the collection and management of the data from virtual visits. While it may not seem hard to “grab data,” the fact is that great care is required in handling data used in clinical research; “If you make decisions on the wrong data, you can cause a lot of grief,” Rosenberg said.
Managing the influx of this data from devices requires new innovative technology that goes beyond the traditional data capture model. “Hybrid trials are going to become something that is going be thought of as more mainstream than it was before,” Rosenberg said, “because the technology works.”
As these changes create a greater focus on the patient, they also bring new responsibilities for trial designers and their technology partners.
First, it’s important to bring patients into the process before the protocols are written. Second, as participants find themselves dealing with more technology and more devices, they need help with these new burdens. Many patients don’t know how the technology works and could decide these trials are less convenient. On top of that, clinical sites also aren’t always tech savvy, so they may struggle, as well. So, there needs to be thought given to providing training and support on everything from device operation to Zoom calls for both patients and sites. Finally, patients also should be part of the trial through conclusion, and be informed about the results – even if the trial was a failure. Trial participants are part of the research team.
Helping drive these changes, too, is what Rosenberg calls “an amazing amount of collaboration” by companies that are working on COVID-19 related treatments and vaccines. They’re sharing scientific knowledge and even offering manufacturing help to companies that have a promising candidate but not the scale needed for the pandemic. “Watching this level of talent and expertise to go after a disease working together is really remarkable, and could only happen in this industry,” he said.
All this work can and should lead to a change in how people who choose to participate in a trial are seen. Trial participants are “making a huge sacrifice, and giving a piece of their body and their time for the greater good,” Rosenberg said. They should be celebrated for that service and be treated accordingly by the industry and by society as a whole. “It would help in terms of the way patients feel about participating,” turning it into a source of pride.
You can listen to Steve’s interview here. We also invite you to download a white paper exploring the role EDC plays in today’s clinical trials and the importance of new technology platforms in enabling its effective use.