Virtual approaches: Come for the cost-cutting, stay for the endpoints
From embedding digital features into clinical trial design, up to the full virtualization of a research project, the possibilities of ‘going virtual’ are in the spotlight for today’s clinical research industry.
During the upcoming SCOPE Summit that will take place in Orlando, US, David Thompson, SVP of Real-World and Late Phase at Syneos Health, will present the company’s suggestions on ‘Going Virtual in Real-World Research: Opportunities & Challenges’.
A week before the event, Thompson spoke to Outsourcing-Pharma about how stakeholders view such technologies and how far the industry is embracing them.
According to Thompson, the main motive for developers is reducing the cost of their research project. “Site management, recruitment and investigator payments are the biggest cost drivers,” said the executive, adding that virtual approaches can “reduce site involvement extensively, if not eliminating [it] entirely.”
In such cases, the level of cost saving is related to that of site involvement, with ‘hybrid’ trials that include ‘some site involvement’ also being an option.
Once the reduction of cost is realized by developers, according to Thompson, the motive that follows is the chance to include novel endpoints in a trial, an ability arriving from the extended use of smart devices and the features supported by those.
“The fact that everyone has a smartphone and [the fact] that these have all these different capabilities, like tracking the GPS location, and therefore being able to monitor mobility, offers the possibility to have a variety of study measures in the trials,” Thompson explained.
Moreover, the executive cited the example of clinical trials in dermatology, in which patients can potentially take a picture of a skin lesion, with the size of it being a trial endpoint, and submit it to researchers in order for it to be assessed and measured.
“These novel endpoints are possible novel approaches for data capture,” concluded Thompson.
Concerns about data precision and regulatory acceptance
Although new possibilities open up with virtual features in clinical trials, with developers being increasingly interested in them, “[developers] are also very conservative.”
Concerns about adopting new technologies, according to Thompson, are mainly seen in developers at Phase II/III stages, since those are critical for gaining regulatory approval, and “they don't want to do anything that would risk hitting that goal.”
Asked about what these concerns are usually related to, the executive cited the precision and quality of the data captured, adding that developers are also worried that such innovative methods of data capture might be rejected by regulatory authorities, in contrast to traditional, accepted methods.
Hesitant developers that want to avoid taking risks also wonder, “What happens if the technology fails?,” and for all of the above cases Thompson explained that Syneos offers the opportunity for developers to try out these technologies in Phase IV, real-world research, where the risks are lower.
Driving the evolution of clinical research
When asked about the evolution of clinical research, Thompson said that virtual approaches for data capture will have a ‘big impact’ on that, but as part of a combination with other trends likely to change the industry.
Such trends, according to the executive, include proliferation of real-world data sources: “Being able to access real-world data sources, and use them to target patients for recruitment into research projects is a huge thing, and it's changing things dramatically.”
More specifically, Thompson explained that digital access to data sources takes the industry one step forward by providing much more informed and proactive approaches to patient recruitment. In combination with virtual trials, the industry “will reach a point in the future when patients will have full ownership of their health records.”
Ultimately, recruiters will be reaching out to patients directly, and patients will be able to give their own consent for participation in a trial, granting access to their health records “with the push of a button,” with developers “not needing the clinical sites anymore.”