What Clinical Trial Experts Think Will Happen With DCTs In 2024
As told to Abby Proch, executive editor of guest columns, Clinical Leader
Heading into 2024, as with any annual flip of the calendar, we anticipate there will be topics of conversation that will fade away, persist, and develop — in the clinical trials industry as in life.
And so, when Clinical Leader asked experts across the continuum about their thoughts for the new year, we got a little bit of everything. Many people opined on the pervasiveness of AI, whether that’s in patient recruitment or regulatory oversight, a few acknowledged the persistence of the decentralized trial in all its many forms, and others saw gains and changes coming in their own therapeutic areas. In part three of this preview of clinical trials trends, experts discuss the state of decentralized trials in all their permutations and muse on their fates as we enter 2024.
Dr. Stephanie Manson Brown, head of clinical development & scientific innovation, VP, Allergan Aesthetics
Decentralized clinical trials (DCTs) have been an emerging topic for a while, gaining momentum with the challenges of the pandemic and will continue to be a focus for sponsors and trial sites in 2024. This area is a work in progress for the industry, but the potential for DCTs is exciting and the road map for the future includes technology integration, patient engagement, and minimizing administrative burden through operational excellence.
DCTs are about people – primarily how sponsors and site staff can adapt how we conduct clinical trials to better serve patients, without compromising data collection or evaluation tools. With an industrywide focus on patient centricity, as well as on diversity and inclusion, we will see more DCT solutions incorporated at the time of study design, rather than attempting to retrofit an approach into an already finalized protocol.
DCT capabilities such as 3D training environments, telehealth, direct-to-patient shipments, patient reimbursements, connected devices, and image capture focus on meeting study participants where they are – essentially in their homes instead of having to travel to trial sites for evaluation. These capabilities and technology advances ensure that DCTs offer patients benefits and don’t just introduce technology for the sake of it. Innovation in this space will no doubt continue and create more pathways for different methods for clinical outcomes and endpoint analysis.
As DCTs begin to span multiple years, we will see more tangible KPIs reported, such as increased protocol compliance, subject retention, and longer-term positive fiscal impact. I expect this will lead to evaluating variabilities in laws and regulations across countries so the feasibility of DCT operations can increase globally.
Sabina Kineen, partner and rare disease patient advocate, Clinical Trials For All
Thankfully, I think the conversation around the ongoing need for decentralized trial options for patients has been effectively heard and communicated over the past few years, so I expect that to fade from the spotlight some as it becomes even more normalized. Patient-centric trial design, though, is a pressing issue that I anticipate will continue to remain a focus in 2024. Sponsors have made great progress with including patients in trial design and trial protocol conversations earlier, but there is still more work to be done. This is one of the most impactful parts of the trial process for patients and caregivers. It sets everyone involved up for long-term success, helping participants have the support they need to stay engaged and ensuring that sponsors and investigators have more patients who are able to commit to the duration of the clinical research process.
Mark Scullion, CEO of Atlas Clinical Research
As 2024 progresses, there will be a shift away from DCTs. This shift will be caused by DCTs not leading to reduced costs, increased patient diversity, and improved retention. While the DCT movement was valuable in pushing innovative ways to conduct trials differently, it has been challenged by costs, complexities for sites, and simple buy-in from those designing protocols. Some aspects of DCTs, like the tools offering patients more choices, will be retained. However, the focus should instead shift to reducing burden for both trial sites and participants, with DCT as something that will remain a sliver of the portfolio.
Dennis Hancock, CEO & president, Mountain Valley MD
An increase in the use of wearables and how they impact participant geography and collection of real-world trial data is a big part of the future shift of how trials are conducted and evaluated. Devices like the Apple Watch, the Oura Ring, and even smart clothing enable data collection in new ways that increase accuracy and minimize historical trial burdens that participants had to navigate. Wearables give us broader access to more communities across diverse age groups, ethnicities, and locations, dramatically increasing the flexibility of how trials are executed, data is collected, and how outcomes are applied to real-world scenarios. And so, hybrid trial models incorporating elements of decentralization will likely continue to be a catalyst in the clinical research landscape.