September 20, 2021
According to a December 2020 survey by McKinsey, 100% of pharma and CROs expected virtual trials to be a significant component of their portfolios, up from 38% in December 2019.1 While the virtual trial model is not a new concept, COVID-19 accelerated its acceptance and implementation in a way that changed the clinical trial landscape forever. ERT estimates that 70-80% of all trials will be a combination of site, local clinics, and in-home locations – a concept known as decentralized clinical trials (DCTs).2
Although the industry adapted quickly to the changing clinical trial landscape, a site survey indicated that only 15% of sites used DCT or virtual trial tools in the past two years, proving that sites must advance their competencies to drive further adoption of DCTs.3 In this article, we share insight from our recent webinar on achieving DCT success, as well as our research studies.
Support patients reluctant to change
While many patients adapted quickly, some remain reluctant to participate in trial activities outside the traditional clinical trial setting. As we drive further adoption of DCTs, it’s important to provide flexibility and optionality to accommodate those who are not ready to embrace virtual and hybrid models fully.
“Providing options for patients is critical,” said Gregory Tuyteleers, Global Lead Decentralized Clinical Trials at Janssen. “I think that is really going to drive patient-centric approaches.”
Work with regulators on better guidance
Despite changes associated with DCTs, one aspect remains: trials must adhere to the strictest compliance and regulatory obligations. Historically, regulators have been slow to accept digital endpoints as data, but they too adjusted amidst the pandemic.
“We saw huge adoption by regulators who really started to work on legislation and guidelines on how to use decentralized clinical trials,” said Tuyteleers.
As regulators accept more digital endpoints, the volume of data will increase exponentially. Madeline Geday, ERT Senior Director and Head of Patient Engagement agreed, stating, “The ability for patients to enter data remotely in a very compliant and reliable way is transforming the way we’re able to access patient data real-time.”
Sites and sponsors must stay on top of the rapidly evolving regulatory landscape to ensure compliance at every step across every geography they operate in.
Mature our tools and capabilities
Embracing technology is an essential step in driving further adoption of DCTs. Juliet Hulse, Senior Director of Global Research, Nurse Strategy and Patient Advocacy at Illingworth Research Group, says technology has had a significant impact from a site perspective.
“We have seen a massive change in the last 18 months with technology with the off-site research nursing,” said Hulse. “We’re being pushed now to do more and more trials off-site.”
Help sites integrate DCTs into their workflow
The ability to conduct trials anywhere doesn’t come without its challenges. An increase in patient-reported outcomes (PROs) requires excellent precision. Sites must manage data in a compliant way that ensures quality without significantly increasing the trial cost.
Embracing DCTs was critical to Illingworth’s continuous operation during the pandemic, as the group saw a 400% increase in RFP requests during COVID-19. Hulse says working with sponsors to create an efficient, cost-effective model allowed more patients to access new medicines.
Personalize protocol design for each trial
Every trial is different and requires a unique design based on its patient population. Tuyteelers spoke on the importance of site design and how it plays into the overall trial from a sponsor perspective.
“We need to start early on at the time of the protocol design, embedding DCT capabilities and looking at what elements make sense to include,” said Tuyteelers. “That early-on planning, early-on engagement with sites is really going to be key.”
Geday agreed, stressing the importance of understanding the patient population and designing trials around fit-for-purpose.
“We really want to understand patient’s health literacy, digital literacy, and the ability for them to access the internet. Really treating patients as partners,” said Geday.
- ERT Virtual Trials and eCOA Strategy, McKinsey & Company, September 2020
- ERT SCRS White Paper, December 2020