Due to the recent accelerated adoption of decentralization in clinical trials, the industry is dealing with the challenges of transition: how to minimize the burden on trial sites and staff; how to manage through sometimes confusing or incomplete regulatory demands; and even how manage the transition itself, which can demand a quantum leap in both technology and process.
One of the main driving forces behind decentralization was the reluctance of participants to come to centralized sites during pandemic lockdowns. Once they discovered they could participate remotely, it made the entire experience easier for them. More people could participate, too, because distance from a trial site was less of a factor.
Yet the process of reducing patient burden often shifted burden to trial sites and operators that found themselves overwhelmed by the challenges of learning new technologies, deploying multiple systems, and a resulting lack of data integration. The key to managing this burden lies in building a technology “ecosystem” that brings different apps together in a unified platform that offers a streamlined environment for gathering, analyzing and acting on data.
Reducing site burden will ensure the industry continues to move swiftly toward the age of decentralized trials. And that, ultimately, will lead to greater accessibility for patients and enabling them to “see clinical trials as a choice,” Alison Holland, Head of Decentralized Trials for Medable, said, “as a part of their health care roadmap.”
Sites also can accelerate the transition by looking for tech skills in new hires, as well as providing skills training to existing staff who want to enhance their technology skills, said Josh Rose, VP and Global Head of Decentralized Clinical Trial Solutions for IQVIA. Input from sites to sponsors about their experience and how to configure technology and processes, can also go a long way toward designing a better trial, he noted.
As sites accelerate development of that technology ecosystem, they may be concerned about the costs of change. That cost, however, is worth the investment because of the type and scale of information that decentralized trials provide, said Jim Streeter, Global Vice President of Life Sciences Product Strategy for Oracle Health Sciences.
“The quality and the data you’re going to get far outweighs” additional up-front costs, he said.
To manage those costs effectively, however, it can be beneficial to see the different decentralized trial features as part of a “toolkit” that allows sites to choose the elements that work for a given trial. That way, they don’t need to undertake all the costs at once, and they can determine the ROI as they go.
In fact, many sites have been doing that already with some legacy technologies, said Craig Serra, Global Head of Clinical Technology and Innovation for Novartis.
“We talk about things like remote monitoring, telemedicine, sensors…patient engagement tools,” he said. “That toolkit has been around in some varying degree for a decade or two. What we haven’t had is sort of the orchestration, all this coming together in a trial or trials at scale.”
A final concern for CROs and sponsors considering decentralized trials is heightened concern over regulatory approvals. They worry that existing regulations don’t account for such trials, there aren’t any new regulations that cover them, and the chances are great that the trial will be rejected.
In most cases, however, “the perceived regulatory roadblocks are significantly more severe than they are,” Rose said.
In fact, rather than being opposed to decentralized trials, a large number of major regulatory agencies are highly supportive of the transition, even if they have yet to provide the same level of regulatory detail that exists for traditional trials.
“I think the major regulators have given us enough verbiage and opinion that we can execute based on that,” Serra said. What’s missing, he said, is “a ton of nuance and…a ton of detail, especially around the how.”
Companies can smooth out the bumps by remaining flexible in designing global trials in order to accommodate variations in acceptance among regulators. Streeter advises companies to engage with regulators early on in the design phase, to ensure they are comfortable with a decentralized trial’s design. With both regulators and trial designers working in tandem, it will lead to better outcomes, he said.
Given all these considerations, Streeter advised to “grow into” decentralized trials, rather than “try to throw everybody into them” right away.
“Do pieces of them, develop your processes, develop your road maps to get over the next couple of years,” he said. “If you’re a pharma company, use CROs that have that experience, gain their experience, work with them [and] the knowledge and experience they already have.”
Contributors in this article shared their insight on the challenges faced in implementing decentralized clinical trials in a roundtable discussion. To view the roundtable, and to read more about decentralized clinical trials visit The Future of Clinical Trials.