When Curavit Clinical Research launched in December 2019, the startup was looking to blaze a new trail in the clinical trial space. Quite simply, they added a “V” before the traditional “CRO,” and positioned themselves as the “first virtual contract research organization (VCRO).”
The timing could not have been more apt — or more of a challenge. The pandemic had supercharged the move toward decentralized clinical trials (DCTs), including virtual trials, and furthered already-strong regulatory tailwinds, Dave Hanaman, Curavit’s president and chief commercial officer, says. But it also created logistical challenges and upended the company’s planned roll-out strategy.
“We fully expected that the decentralized market, while small, was going to grow at a steady pace and a lot of that would come from Big Pharma,” Hanaman says.
But trials at large companies had suddenly come to a screeching halt.
“Big Pharma was suddenly working from home and if you weren’t doing COVID trials, but you were in clinical research, then you were sitting at home, and you were planning things for post-COVID,” Hanaman says.
Curavit pivoted quickly, focusing even more of its attention on small and midsize companies.
“Big Pharma has the luxury to be patient and that’s appropriate. Small, midsized biotech start-ups don’t,” he says. “They’ve got venture capital, they’ve got a binary equation on success. They’re either going to be successful or they’re not.”
Many early adopters of DCTs have historically been bigger companies, in large part because they have the resources to make the transition. But it’s actually smaller and midsize biotechs that stand to benefit disproportionately from decentralization, Hanaman says.
For these companies, DCTs have provided a lifeline to keep research moving.
An outsized benefit
For smaller pharma companies, DCTs can mitigate a number of challenges — from recruitment struggles to global deployment challenges. Decentralization can also help expedite trials, allowing them to adapt quickly in response to data.
Drugs and diagnostics at small to midsize companies typically target a focused, distinct audience, and often focus on rare diseases, Hanaman says.
“Decentralized trials allow them to recruit from all over the country or potentially all over the world,” Hanaman says.
Decentralized technology can also help facilitate global, multi-site trials, says Alison Holland, executive general manager, Digital and Decentralized Solutions for Medable, a software provider for decentralized trials.
“Very few companies, including the small to midsize, are working in just one jurisdiction,” Holland says. “They’re looking for broader exposure, broader registrations.”
According to Holland, decentralized trial providers can help to plan for site-specific needs, accommodating for local data collection, privacy, and regulatory requirements, which can vary by country.
DCT technologies and devices can also speed trials, allowing for more data collection in a shorter period of time, with greater efficiency and reach, Hanaman says. Researchers can then interpret this data more quickly and accurately, which can enhance patient safety, and encourage participation and participant satisfaction. For example, if a red flag is detected on a daily measure of blood pressure, heart rate, temperature or weight, the subject can be brought in for evaluation quickly.
DCTs also make trial participation more appealing because they require less hassle and travel to research sites. Easing the process helps to encourage those who might otherwise be reluctant to participate. This is particularly true for people who are in poor health, such as oncology patients.
“If home is a relaxing, safe environment for them, they might appreciate the option to be there,” Holland says.
Understanding the challenges
There are also some inherent challenges for small to midsize biotechs that chose to go the decentralized route. First, DCTs require an up-front investment, not only in terms of dollars, but of time, focus and energy, Hanaman explains. Making the leap ultimately enables these organizations to run more efficient trials going forward — but they have to get over that initial hurdle first.
Second, deviating from traditional research practices can bring risk and scrutiny.
“If everybody adopted DCT technologies and processes then everybody would start to benefit. But when one company does it, they expose themselves, correctly or incorrectly, to be challenged on their results,” Hanaman says.
For others, the main challenge is overcoming paralysis. Many companies are interested in DCTs, but simply don’t know where to start.
“It’s such an overwhelming thing,” Holland says, explaining that companies often don’t know how to adapt technology to their individual study.
For all of these reasons, many smaller organizations choose to dip a toe into the water rather than jump in all at once.
“A vast growing middle section of trials are hybrid, and that’s really where companies can and should be,” Hanaman says. “You don’t have to be all in on one or another. One can say, ‘What are the technologies that work for us? How do we design our trial from these digital first principles, and then add in traditional components in a way that is better for patients, better for research, better for outcomes?’ And that often is in this hybridized space.”
Strategies for successful implementation
In order for decentralization to work, it has to be implemented correctly. Some companies try to design a trial in a traditional way and then shoehorn in technology, Hanaman says. Instead of being more convenient for participants, the end result is a clunkier trial that increases the burden because participants still need to go to the site, but they also need to learn the technology.
Instead, companies should take a more comprehensive planning approach.
“I would encourage everyone to not to get overwhelmed by the breadth of what a DCT could be and to think about their protocol,” Holland says. “What’s the scientific question that their protocol is trying to answer?”
In particular, she advises that companies ask how they can answer that question in a more digital fashion, that allows for choices for the site and the patient.
Both Hanaman and Holland suggest consulting with DCT support providers as early as possible in the trial design process. This can help determine how technology can best be used to achieve trial aims. Ultimately, successful DCT adoption requires a focus on one core goal, Holland says.
“DCTs aren’t about no bricks and mortar, or no sites — it’s about amplifying the relationship between the site and the patient,” she says. “If we approach it from the perspective of ‘How do we engage patients with their clinicians and caregivers more?’ then it really opens up a huge opportunity for us to transform how we deliver healthcare and how we collect data.”