While the pandemic knocked many clinical trial operations for a loop, the decentralized clinical trial (DCT) format has fueled a comeback since COVID-19’s arrival. Dave Hanaman (co-founder, president, and chief commercial officer of Curavit) spoke with Outsourcing-Pharma about progress made, lessons learned, and the road ahead.
OSP: How have decentralized trials evolved in the past two years?
DH: The biggest evolution has been the adoption of decentralized clinical trials (DCTs) by sponsors that would not have considered them without the catalyst of the pandemic. Before the pandemic, DCTs accounted for only 2-4% of trials and were projected to increase about 10% over the next 10 years. The pandemic and lockdowns forced the industry to get creative.
While there was a feeling early on that the use of DCTs might decline when the pandemic was over, the benefits of the model and the continued threats of new COVID variants proved otherwise. Now the DCT market’s estimated value is a staggering $1.63b USD by 2027, an annual growth rate of 14.8%, according to Precision Reports.
Much of this growth over the past six to 12 months is a result of the exploding digital therapeutics (DTx) market and their adoption of DCTs. According to Report Linker, the global DTx market is projected to reach $13.1b USD by 2026, up from $3.4b USD in 2021. These DTx companies are bringing novel software-based therapies and diagnostics into the market and their business and delivery models line up almost perfectly with DCTs because of the way these trials are designed from digital-first principles.
OSP: Please share your perspective on some of the aspects of DCTs that the industry still tends to struggle with.
DH: DCTs are rapidly evolving in an environment that tends to resist change so there are some natural tensions and uncertainties, and it will take time to iron those out. One challenge is the need to define and agree on novel digital endpoints. DCTs require new endpoints that are collected with new devices, and in ways that are different from traditional methods.
Establishing and gaining acceptance of novel endpoints by both the FDA on the regulatory side and principal investigators on the sponsor side will continue to be a challenge in the near term. Fortunately, the FDA is ahead and has shown great support for adopting novel endpoints and breaking away from the traditionalism of clinical research.
Companies will also continue to struggle with designing trials from digital-first principles from the start. Many decentralized trials, especially with the catalyst of COVID, have been designed as traditional trials that later became decentralized trials to ‘rescue’ the research. Sponsors often try to shoehorn digital technologies into traditional designs, and they end up with the worst of both worlds; traditional heavy site footprints with cumbersome technology that may not best suit their research requirements. This can be costly, time-consuming, and inefficient.
The industry is continuously evolving, and with the development of new technologies to improve DCTS, including better ways to collect endpoints, analyze data, and manage virtual processes, sponsors will likely continue to adopt these new innovations to enhance their research.
OSP: Could you please talk about some of the lessons the industry has learned about how to design, recruit for, execute, collect data, and otherwise run DCTs?
DH: It’s important to note that DCTs are not a panacea for research if the design is not well thought out from the start. It’s imperative to take considerable time upfront developing methodologies and endpoints, and then selecting the technologies to be integrated.
As described earlier, the shoehorning of technology into traditional trials in the name of improving the trial could increase the patient burden. For example, if participants in a traditional trial are later asked to adopt an ePRO, it might disincentivize them to continue participating since they must learn a new technology, on top of multiple site visits.
Another misunderstanding is that with a DCT model, patient recruitment is easy. While it may enhance the process, it is still hard to keep patients engaged. So, while these technologies provide new tools to recruit patients and reach a wider population, we still must get back to basics in terms of patient engagement. Technology does not absolve sponsors of the importance of establishing, building, and maintaining relationships with patients.
Regarding data collection, DCTs have the incredible potential of collecting more data from more patients across different locations and demographics over a shorter period of time, and potentially around the clock. Traditional data analysis resources cannot always adequately handle these large data sets and require a new set of skills, tools, and expertise.
OSP: In your opinion, what are the advantages to starting a trial as a DCT from the drawing board compared to changing from an onsite to a DCT or hybrid?
DH: The metaphor ‘measure twice, cut once,’ applies here. From the start, it’s key to call on experts who understand digital-first principles when developing the trial protocol because the industry is constantly evolving and it’s difficult to keep up with new technologies, how they are deployed, and the risks and rewards of integration.
By starting with a DCT from the onset, sponsors build a study aligned with the selected study model for a more streamlined, efficient, and patient-centric trial without the heavy (and expensive) footprint of a traditional trial with a lot of cumbersome technology tacked on unnecessarily.
OSP: Curavit describes itself as a ‘virtual clinic trial organization;’ can you explain what that is and what the difference is between a VCRO and a CRO that runs DCTs when needed?
OSP: We describe Curavit as a VCRO, and we’ve been credited as the world’s first all VCRO for two reasons. First, we established the company two and a quarter years ago prior to the pandemic in December of 2019, and our focus from the start has been exclusively on designing and executing virtual or decentralized clinical trials. It’s important to note that we truly are a virtual organization that runs our business, as well as our trials in the cloud. Because of this, we can hire the best people wherever they happen to be.
The difference between a VCRO and a CRO that runs DCTs all comes back to that idea of original design. There are many great CROs that run traditional trials and will continue to do so. They will also continue to adopt digital technologies to run hybrid trials, but a true VCRO looks first to digital technologies to fully design and execute trials and only relies on proven traditional methods where digital methods are not yet capable of providing solutions.
OSP: If you could, please share a DCT your company worked on and some of the unique aspects of the study.
DH: I’ll give you two examples. In the summer of 2020, we designed and executed a DCT for Beach Tree Labs for a COVID therapy using an existing drug that was looking for a new indication. This is a perfect example of a company that would have loved to have done a traditional trial as they were accustomed to. Beach Tree commissioned a traditional CRO but had to suddenly shift gears to design a DCT because it was the only type of trial that could be done during the height of the pandemic. They came to Curavit to contribute to the DCT component of the design and pull together the technology. We were able to deploy and complete the trial in just four weeks; one of the advantages of a DCT.
The second example involves a DCT that we’re currently executing for a DTx company. What’s unique about working with digital therapeutics is in most cases the therapy is the software itself; and so, the therapy being tested is in fact the software.
In this case, the trial was not only designed using digital-first principles but the endpoints are being seamlessly collected within the application itself. Because DTx companies are innately digital, they are quickly adopting DCTs as the best model for research.