Human element important for decentralized trial advancement
Approximately two years after the pandemic morphed the decentralized clinical trial (DCT) from an emerging format to a necessity, the industry has learned numerous lessons about how to operate a DCT, as well as the benefit of incorporating DCT technology into an operation. However, as a trio of industry veterans shared during the recent Decentralized Trial Technology webinar, there are still lessons yet to learn in order to make the most of DCTs.
On July 20, Outsourcing-Pharma hosted leaders from CVS Health, the Association of Clinical Research Professionals (ACRP), and the University of Chicago Medicine to discuss issues impacting the field. The representatives discussed common misconceptions about DCTs, patient considerations, novel tools and technologies, and more.
Mohammed Ali, an ACRP board member, shared that ACRP’s mission focuses on increasing the quality of clinical research overall through the direct impact of professionals that manage clinical studies, “to deliver the highest outcomes for patients worldwide.”
Ali pointed out that the DCT format emerged, long before COVID-19 arrived on the scene, as a way to help manage a range of challenges, from cost and resource constraints to patient burden considerations.
“A decentralized clinical trial looks to deliver research in a remote capacity to increase access and democratize research for the majority of its participants as well as sponsors,” Ali shared, adding that other concerns associated with traditional-format trials (such as drug stability and patient safety) do not go away with the change in location.
Additionally, Ali pointed out, the DCT option might not be the best for a study, so a number of things must be weighed.
“You want to make sure that there is some level of assessment and comfortability before moving on to the aspect where you can go ahead and conduct research outside of a clinical facility; the protocol design is also a key consideration,” Ali advised. “Several design considerations here should include assessments which are not so invasive or require heavy infrastructure—keep in mind that this is going to be quite a large issue, so you cannot potentially have every protocol being done remotely 100% but potentially a hybrid approach could also exist.”
Ali also shared the importance of learning and training resources, such as the on-demand learning resources ACRP offers.
The second presenter Walter Stadler is a professor of medicine and dean for clinical research at the University of Chicago Medicine. Overall, Stadler commented, clinical research and drug development professionals face a number of common, very serious challenges.
“I think that we can all agree that trials are currently too slow to activate, too slow to accrue, too expensive, and have insufficient subject diversity, and we all understand that academic health centers contribute to these problems,” he stated. While several lawyers and multiple institutional review boards can contribute to complications and slowdowns in a study in their efforts to cross all the Ts and dot the Is, protect patients, and more, their work is important, and a DCT can help streamline.
“The promise of centralized approaches is in many ways to cut out an expensive middleman; there can be a single IRB, fewer site contracts, and as a result, faster startup,” Stadler surmised. “It also serves to bring the trial to the patient with greater convenience that will hopefully be faster, and there is at least an opportunity for greater subject diversity, given the well-known challenges of underserved communities in accessing sites where trials are typically conducted.”
The benefits of opting for the DCT format, Stadler added, may be increasing as time goes on.
“The technologies to support decentralized trials have matured rapidly over the last few years; everyone has a cell phone, there can be virtual symptom monitoring not only with wearables but also with simple patient-reported outcomes that can be completed in response to a text rather than completing a paper form,” he said.
Additionally, Stadler said, patients may have the option of going to a more convenient secondary site for getting lab tests, and (thanks in part to the increase in the use of remote doctor visits since the advent of COVID-19) patients are more comfortable with telehealth technology.
That does not mean, however, that DCTs do not present zero challenges, Stadler said. Sites and sponsors have to deal with selecting the right local partners, patient recruitment, interacting with primary physicians, data collection, and other issues.
Josh Rose vice president of CVS Health Clinical Trial Services, mused that the DCT format has the potential in and of itself to help address some of the challenges the clinical research industry has been wrestling with in recent years, including increasing recruitment of underrepresented populations, managing the level of patient burden, better meeting enrollment targets, staffing woes, and more.
“Studies are difficult for patients in their existing format and as a consequence of that burden contribute to the low patient recruitment and enrollment,” Rose commented. “There's also an element of trust, like interacting with health care providers that we're familiar with, and some of the challenges that we're seeing is this absence of trust is contributing.”
To deal with the myriad challenges associated with clinical research, Rose said, a “transformation” is called for. However, before that can truly take place, the industry needs to deal with some of the common misconceptions around DCTs, including the definition of a decentralized trial and all that they entail.
“What is at the heart of decentralized clinical trials? At the heart of it is the fact they’re patient-centered, they're more patient-friendly,” he said. “At their core, they are constructed in order to reduce patient burden, reduce complexity, make it easier for patients to participate—and if we make studies more patient-centric, more human-centric, more patient-friendly, a lot of the issues take care of themselves.”
One important thing to keep in mind, Rose advised, is that while DCTs can be helped and significantly driven by technology, the human elements necessary for a trial’s success should not be forgotten.
“It's not correct to assume that they're without human interaction, because they are done with a lot of human interaction; it's just done differently,” Rose remarked.
CVS is looking to contribute to clinical research progress in a number of ways, centered on patient engagement and opportunities, Rose shared.
“Within one study, some of the visits may be at home, some of the visits may be remote, and then we evolved towards what we refer to here at CVS is community-based clinical research, which is hybrid studies, but where many of the activities are actually taking place in the community, at pharmacies and other locations that are much more patient-centric,” he said. “It's really important to think about this as a continuum, as opposed to it's one or the other., and that’s the way the industry is looking today.”
Rose told the webinar audience that CVS is working toward studies simpler and more engaging for patients to encourage enrollment (and avoid dropouts). The company, for example, has converted a number of its Minute Clinic community care centers into research sites. Among the benefits of this approach, he said, is the existing familiarity with the CVS name, brand, and locations.
“They are familiar to patients—many patients visit Minute Clinics for their normal care, so when they visit for clinical research, that aspect of trust that we're talking about is very high,” Rose said. “When we surveyed patients and we asked them how they feel about clinical research at a Minute Clinic, the responses are super positive.”
Incorporating CVS into a patient’s study journey can create a more convenient, seamless experience, Rose said. The location is near their home, whereas an on-site study might require significant travel time, and their interactions are with a company they are familiar with.
The Decentralized Trial Technology online event might be over, but the on-demand version is still available for professionals interested in learning more about DCTs and hearing from the trio of experts. Sign up to enjoy the webinar recording.
