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Curavit Talks to Clinical Trial Sponsors At CNS, DTRA, and OCT

“Decentralized trials are not just about software!”

By Joel Morse
Curavit Clinical Research

Last week was jam-packed with three industry events back-to-back. Curavit, like many of others in our industry, attended all three – CNS Summit, DTRA Inaugural Summit, and Outsourcing in Clinical Trials, New England the week of Nov 7. We had the benefit of speaking andidly with clinical research stakeholders from across the ecosystem, from technology providers to sponsors and CROs.

One of the most unexpected takeaways was the feelings of frustration from sponsors who are ready to move on from “talking about improving clinical trials with software” to “actually improving clinical trials with a new set of solutions.”

In fact, one large pharmaceutical company spokesperson said, “It’s not a platform, but a process. Companies seem to be just selling software.” Another remarked, “The approach to DCTs feels like we’re in a bubble.” Still another did not mince words when he said,”This is all BS. Vendors say that it is all rosy, but it is not.”

One speaker who aimed to debunk the myths of DCTs and spoke in support of technology conceded that a lot of the expensive tech available right now is garbage. Another speaker from Anika Therapeutics described what he thought vendors needed to consider to successfully implement various wearable and tech devices as part of their study. He suggested 24/7 support service, a budget to recycle/restock devices, reliable network access where patients reside, integrating e-diaries with EDC, maintaining a large inventory of provisioned devices, and more. Overall, at OCT, the message to vendors was this: we are starting to ease patient burden while cutting the fat in standardly run clinical trials but there’s more to be done, and it requires more than technology to do it.

Tech vendors: Take heed of the warnings. Pharmaceutical companies are looking for specific solutions to address very specific problems, and technology is just one part of the equation. Here are the top things I heard that sponsors want from technology vendors:

● More focus on end state
● Holistic study design expertise
● Regulatory expertise
● Patient experience – follow the patient throughout the life of the trial
● Decentralized methods to target specific improvements
● Quality of data

Are we delivering? The good news is that there are several examples we can point to that demonstrate how we are delivering in the area of DCTs. However, from a macro perspective it appears that this is still up for debate. Technology providers must step up to all of their promises if we want to fulfill our industry wide mission to improve the clinical research process and bring trials into the next century.

As a digital CRO, Curavit has a lot to prove to sponsors – especially given this feedback. The good news is that we have some real-life examples, such as the Beech Tree Labs (BTL) clinical trial we presented during the CNS Summit.

Curavit engaged with BTL in Q2 2020 to design and execute a fully decentralized clinical trial. BTL had an existing indication that they wanted to extend as a Covid19 therapeutic and wanted to test in a Phase 2 trial with 60 COVID-19-positive patients that were well enough to remain in their homes. In eight weeks, Curavit finalized the study requirements and enrolled the first patient. Here are the steps we took to accomplish this goal:

● Finalized the protocol to reflect a purely decentralized clinical trial
● Designed and implemented the ePRO and eCOA solutions
● Stood up a patient screening, e-Consent, and enrollment process
● Trained the patients and study team on the technology and clinical trial process

Clinical trials are not simple – technology should lessen the complexity, not increase it. Yes, technology can be, and should be, leveraged to reduce friction and increase effectiveness. However, technology doesn’t do it alone. To truly “move the needle,” the industry must examine clinical trials holistically to drive improvements across technology as well as people and processes.

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