Why Jane Myles Believes DCTs Are "Completely Doable"
By Dan Schell, Chief Editor, Clinical Leader
Jane Myles vividly remembers when she first heard about the Decentralized Trials & Research Alliance (DTRA). It was 2020, and she had just joined LabCorp (owned by Covance) after a decade at Roche and five more years at Genentech in ClinOps roles. After telling her boss that the company should be a part of the DTRA, she was surprised to hear it already was. “So, I said, ‘Great, I'm taking your leadership spot,’” Myles recalls. After asking her why he should let her do that, she explained, “Because I know Craig [Lipset, one of the DTRA founders] pretty well, and I'm deeply invested in what they're working on, so I think I can actually help us by taking that spot.” Her boss agreed, and from then on she has been closely involved with DTRA. In fact, today she is a full-time program director for the cross-industry collaborative group that was formed to make clinical research participation accessible to everyone by enabling the use of “consistent, widespread adoption of appropriate decentralized research methods.”
THE EVOLUTION OF THE TERM DCT
In terms of a hype cycle, DTRA was formed (December 2020) during the early stage when DCT interest was high. In the ensuing four years, a lot has changed regarding industry perceptions of exactly what a DCT is and its feasibility. As noted in our recent Clinical Leader Live, “Last Year's DCT Is Today's Clinical Trial,” the notion that a DCT must be a siteless trial is already outdated — in most cases. “Although some of us have been working on this for more than a decade, yesterday, I had at least two conversations where people who are working in this space told me that their peers or their customers still perceive that decentralized trials means fully remote,” Myles says.
AN EMPHASIS ON THE SITE VOICE
Like the evolving views of the term DCT, DTRA also has changed since its inception. For example, the organization is currently working on defining a RACI (responsible, accountable, consulted, informed) — i.e., best practice — for who is responsible for certain aspects of the setup and execution of a DCT. That’s especially important these days as sites often can feel overburdened when faced with the prospect of having to take on the training and support of DCT technologies. “The DTRA is refocusing our terminology and messaging around patient access,” Myles says. “Because that’s really the purpose of DCT method utilization. The challenge is doing it in a way that is helpful to sites as well as patients.” She says efforts such as the aforementioned RACI, allowing sites to use technology they are already familiar with (i.e., BYOT), and including the site voice in trial design are all underway. The latter is a collaborative initiative with TransCelerate, which is very interested in making sure sponsors get access to those site voices.
RESPONDING TO THE FDA DRAFT GUIDANCE
After the FDA issued its draft guidance on DCTs in May 2023, a process was set up at the DTRA for members to provide feedback on any aspect of the guidance. By the end of June, the organization’s regulatory affairs council started gathering that feedback for review. Myles says the role healthcare providers could have in clinical research was commonly questioned (e.g., When can an HCP support a clinical trial without becoming part of the investigational team?)
“We had a conversation with some of the folks who had authored the guidance, and they said, ‘We need some examples to help make all of this clearer,’” says Myles. “I was fortunate to be the project manager of a team working on questions such as How do you manage regulatory documents like the 1572 and the delegation of authority? What exactly is a task log? and Who actually is a healthcare professional versus who is part of your study team? So, we took our outputs from that team and added them in as an addendum to our main comments.” Ultimately, approximately a 60-page response was submitted to the agency.
BUILD IN, DON’T BOLT ON
When talking with Myles, she frequently would refer to “patient-facing innovation” and the need to reduce “friction” when building in — not bolting on — DCT components. “If you're not super intentional and designing with the end in mind, [the DCT element] creates a lot of unexpected friction in the workflows for the sites — and for the patient.”
For instance, say you’ve got a trial where you give the patient the option of visiting a site or having an in-home visit. You understand and are prepared for what needs to be done in either situation (e.g., you have an HCP who can go the patient’s home). So, you’ve built-in optionality, which is great, but now you’re faced with a new challenge: figuring out when a patient must tell you which approach they choose. After all, if they are going to the site, you need to ensure all the materials are there and the staff are prepared for the visit. The same is true for a home visit, which likely is more difficult, because those materials (e.g., IP, vials, centrifuge, etc.) may not already be onsite. Furthermore, you'll need to know if there is someone in your provider network who can be at the home — when convenient for the patient — and stay as long as required and get the data back to the PI or even have a televisit with someone from the physical site, if needed. “It’s those layers of details that you must think through really carefully when decentralizing a process,” Myles concludes. “It is completely doable. You just need to make sure all of the separate bits of the process are in place and the folks responsible for executing each step are highly committed to making sure it gets done.”