Where Do We Stand With DCTs Heading Into 2025?
As told to Abby Proch, executive editor of guest columns, Clinical Leader
If we consider the position of DCTs on a hype cycle (you know, that line graph that tracks the introduction, implementation, and success of a new technology), then we’d likely find it somewhere along the path between disillusionment and enlightenment. Clinical research professionals have heard the hype, they’ve brought DCTs into the fold, they’ve had some hiccups, and now they’re trying to work through performance issues toward more widespread success and adoption.
Basically, they’re at the point of muttering “not again” when someone brings up DCTs in conversation. However, if one truly believes in the transformative power of decentralizing elements of a clinical trial, we should forge ahead with these conversations.
So, in that spirit, Clinical Leader asked familiar voices and new faces alike: “What’s left to say, to understand, or to do with DCTs (or elements thereof) in 2025?”
Here’s what they had to say:
| “As we look to 2025, several key areas warrant further exploration. First, improving data integration and security will be crucial, ensuring that patient data remains private while facilitating interoperability. Enhancing patient diversity and accessibility is also essential for achieving representative trial populations, requiring tailored designs to address barriers. Additionally, regulatory harmonization across regions can simplify international trials and boost efficiency. Optimizing emerging technologies, such as AI and remote monitoring, will further streamline processes while maintaining user-friendliness for patients and researchers. Finally, understanding how to sustain long-term patient engagement in lengthy studies is vital to improve retention and the quality of outcomes. Addressing these areas will significantly enhance DCTs’ effectiveness and patient centricity, benefiting the entire healthcare ecosystem.” | Yen-Ching Chua, head of clinical operations, Debiopharm |
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“Travel, even to appointments, can be a burden to our cancer patients. They deserve options, and DCTs in oncology clinical trials provide these opportunities. The COVID-19 pandemic made DCT an important and integral part of cancer clinical trials, with many sponsors thinking outside the box so that research could continue during quarantine. Subsequent design studies have optimized these trial plans. As a result, in 2025 and beyond, DCTs will provide more access to novel therapies for our cancer patients. In addition to providing accessibility to our patients, the availability of DCTs may enhance enrollment and provide some economic benefit to patients regarding traveling time and cost.
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 Wasif Saif, MD, MBBS, medical oncologist leader, Phase 1 clinical trials multidisciplinary team co-leader, Gastrointestinal and Neuroendocrine Oncology Multidisciplinary Team, Karmanos Cancer Institute |
| “In 2025, our focus must remain on driving the acceptance and usability of DCT elements at the site level. Despite our progress in identifying the challenges of utilizing technology and remote services, many issues remain unsolved. Prioritizing fair compensation models, right-sized and efficient training, and consistent, user-friendly interfaces will be crucial. By addressing these areas, we can enhance site engagement and operational efficiency, ultimately moving clinical trials forward more effectively.” |
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| “We need to (1) collaborate to gather evidence of what methods are generating meaningful impact and in which types of studies, (2) work together to understand and respond to adoption barriers with different stakeholders, (3) ensure technology and service providers are positioned to support delivery excellence, and (4) restore proper resourcing in sponsors as they recover from a year of organizational change. Together we can then deliver on the shared commitment of making research accessible for all.” |
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| “DCTs will continue evolving, but there’s still much to explore, particularly when it comes to refining the patient experience and ensuring data integrity. Geneoscopy’s PMA study for ColoSense — the first colorectal cancer screening test to receive FDA approval using a fully decentralized model — demonstrated immense potential for increasing accessibility and diversity in clinical research. We must focus on standardizing data collection methodologies across diverse devices and home settings while ensuring regulatory bodies can consistently assess these new models. We must also enhance patient engagement tools to maintain compliance and improve retention in long-term studies. The challenge is not just scaling DCTs but integrating them more seamlessly into existing healthcare systems, bridging the gap between innovation and routine practice. The future depends on optimizing this integration to ensure smoother, more efficient adoption.” |
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"We’ve only scratched the surface of DCT potential! Now that the FDA has published its final guidance, we can get to work. You’ll likely see in 2025 the interpretation of FDA guidance from sites and sponsors and the development of acceptable industry practices across the industry. IRBs will begin to approve protocols that call out decentralized elements in protocols, sponsors will begin to vet and utilize doctors’ offices as vendors just as they do home health, and trial reach will expand far beyond brick-and-mortar buildings in our communities. I am hopeful that the next year will be the true inception for our industry’s DCT universe." |
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Can’t get enough of DCT talk?
Catch up with these guest experts who shared their insights on DCTs throughout 2024.
The Rise, Fall, And Eventual Rebound Of DCTs, by Nael Abdelsamad, MD, MBA, FACHE, CPI
The 3 Big Downsides To DCTs, by James Gillespie, Ph.D., and Gregory Privitera, Ph.D.