A boom in decentralised clinical trials was an unexpected effect of the COVID-19 pandemic and subsequent lockdowns. However, these trials require expertise and technology that can differ significantly from those needed for clinical trials, as Curavit Clinical Research’s Joel Morse writes in the DIA Global Forum’s special November 2022 issue on the Digital Virtuous Loop.
There’s more than one way to architect a decentralised clinical trial (DCT). While this flexible model has many benefits, it can be overwhelming to bring together all the right elements to operationalise a trial that’s predominantly digital. Every trial is unique, so it is not realistic to templatise (impose a standard implementation template on) a DCT. But four common, fundamental components combine to facilitate a seamless, patient-centric DCT.
“It’s like a trial in a box, but each box is a little bit different,” said Steve Rosenberg, CEO of a cloud-based platform company that powers decentralised clinical trials. Even with a DCT’s inherent optionality, foundational components can ease implementation and improve execution.
1. Expert Protocol Design Review: What Can Be Decentralised?
Traditional clinical trials are complex, but architecting a DCT from the ground up is even more complicated. And while nearly nine in 10 sponsors say they use some elements of DCT technologies in their trials, fully virtual trials are still rare. At a recent conference, one top-10 pharma executive said that while more than half of their trial site visits are virtual, no trials are 100 percent virtual.
One reason for this is that designing a DCT protocol requires highly specialised expertise. Sponsors are leaning into the decentralised approach to speed patient recruitment, increase access and diversity, improve efficiency, and capture real-world data, but are still developing protocol designs within a traditional framework. Expert DCT protocol designers, however, review trial designs to determine what aspects can be decentralised (and which cannot) and the best way to decentralise those elements. They factor DCT considerations into the process from the beginning, instead of shoehorning digital elements into the trial later or superimposing them over traditional designs.
The best resources are experienced in clinical research, the therapeutic area of the trial, and DCT technologies. These experts know how to allocate the right DCT resources to allow for maximum patient flexibility during the trial. For instance, a lot of calendaring is often involved in planning a DCT since the patient is not tied to a specific location. It becomes critical to ensure that there are enough calendar slots for televisit appointments at optimum times for patients. A DCT protocol design expert will take all resource considerations into the design, thinking ahead about what can be done by a coordinator instead of by a clinician or registered nurse and other ways to optimise staffing.
2. Patient Solicitation Partners: Recruit, Screen, Consent, and Enrol
Patient recruitment is notoriously time-consuming, but many technology-enabled firms leverage solutions specifically for a DCT. For example, one patient recruiting firm targets potential patients on digital channels using sophisticated targeting, patient-centric recruitment, and technology. Once a patient clicks on an ad, they are taken to a self-service landing page with more info about the trial and self-screening questions. If the patient passes, they can immediately schedule a live screening call, eConsent, and enrol in the trial.
One virtual CRO specializing in DCTs collaborated with this patient recruiting firm on a trial of an investigational DTx for chronic cardiovascular disease. Through targeted ads on key digital channels (i.e., Google, Reddit, Facebook, Instagram), the CRO recruited 50 patients in 10 days, surpassing the sponsor’s originally estimated four-week timeline. In addition, 39 percent of patients who clicked on an ad completed the pre-screen form – again, beating a projected 24 percent completion rate. In total, the CRI and the patient recruiting firm recruited, consented, and enrolled 150 patients in just 58 days.
“Most recruitment methods miss opportunities to enrol patients, whether in finding the right people or communicating the opportunity correctly. Expert recruitment processes coupled with technology-activated enrollment at the site and CRO levels fill trials faster with less friction,” said Dan Brenner, CEO and founder of the patient recruiting firm. “Digital recruitment allows more patients to be enrolled in the right trials, seamlessly. It breaks down the barriers between patients and studies, increasing access for more patients.”
One independent software company optimises the use of data to digitally recruit, screen, and consent patients in DCTs. With access to 350 million lives of anonymised medical records globally, and 200 million lives of anonymised claims data in the US, the firm uses a data science-based approach to target patients across a large geography.
“In DCTs, there’s a longer-term opportunity to marry enrollment and operational data to continuously learn and refine the patient recruitment and enrollment process,” said Matt Walz, its CEO. “How else can we use this data to improve trials? For instance, this data could inform protocol development so that sponsors can better assess how inclusion/exclusion criteria might impact enrollment. All this data can improve how we work with patients.”
In the end, whichever partner supports the enrollment process, data must be aggregated on a single platform for a seamless site and patient experience, and as an opportunity for continuous improvement. “DCTs expand access to patients who live a distance from academic centres, but they can also add burden,” Rosenberg continued. “For instance, patients must decide about each visit: Does someone come to their house, do they stop at a CVS [pharmacy], or go to the clinic? It is important to consider the impact of this new experience on patients. DCT technology enables us to survey patients in real-time and then find ways to alleviate any unforeseen issues.”