Redefining the Patient’s Journey with DCTs
Imagine you’ve just learned about a new clinical trial for a treatment that could change your life. There’s a catch? In the past, participating would have meant frequent trips to an academic hospital or research site far from where you live. Committing to study visits at either location requires navigating through traffic and spending hours away from your daily routine. This scenario is shared by many who have a desire to participate in a clinical trial. But now, there’s a different option available to clinical trial participants—the Decentralized Clinical Trial (DCT).
A New Kind of Clinical Trial
A Decentralized Clinical Trial is designed with you—the patient—in mind. These trials bring research to your doorstep or close to home, leveraging technology and sometimes, but not always, local healthcare systems to make participation more manageable, convenient, and accessible. There are two variations of decentralization: fully decentralized or hybrid. DCTs are clinical trials outside a single central location or partially decentralized. These two variations differ from a traditional clinical trial, which requires participants to visit a research site for study visits, where clinical research, development, and testing can occur with in-person oversight. No matter where you live, a DCT can reduce the barriers that once made clinical trials feel out of reach for many.
Fully Decentralized Clinical Trials often use digital health technologies (DHTs) to collect and transmit data and conduct study visits via the phone or video calls. From wearable devices that track vital signs to apps that record daily symptoms, these tools provide a comprehensive picture of a patient’s health without requiring frequent in-person visits. In addition, study materials, including forms, information, medications, and devices, are mailed to the participants, and sometimes local pharmacies can provide medications.
Hybrid trials are a type of partial decentralization that can be more or less site-centric. They can include remote elements like at-home visits, mobile clinics, and electronic consent (eConsent). However, hybrid trials may require traditional site visits for complex procedures and specialized assessments. For example, people could participate in the trial through a local doctor’s office just a few miles from their suburban home rather than traveling to a distant research center. Hybrid trials can also utilize DHTs such as digital diaries so that participants can note their symptoms, and then this information can be transmitted to study teams for monitoring.
Meet Sarah: A Patient’s Story
Let’s follow the journey of Sarah, a hypothetical person and a busy mother of two who recently joined a fully Decentralized Clinical Trial for a new asthma treatment. Sarah’s life is hectic, with school runs, work commitments, and caring for her family. The idea of traveling to a research site multiple times a month felt overwhelming, but she was eager to participate in the trial. When her doctor mentioned the option of a DCT, Sarah was intrigued.
How a DCT Fits into Sarah’s Everyday Life
In a traditional trial, Sarah might have needed to visit a research site hours away. With the DCT, the study visits came to her. After enrolling, she received a wearable device in the mail—an easy-to-use wristband that monitored her daily activity levels and breathing patterns. There was no need to take time off work or arrange childcare for hospital visits. Instead, Sarah put on the device and went about her day.
The wristband wasn’t just a gadget; it was her connection to the study team. The device transmitted data wirelessly, allowing researchers to monitor her health in real time. They could contact her immediately if they noticed anything unusual, ensuring she felt supported and connected.
Convenience Without Compromise
One of Sarah’s favorite aspects of the DCT was its flexibility. She had regular video check-ins with the study team and a principal investigator overseeing her progress in the study, allowing her to ask questions and receive guidance from her home. No more long drives or waiting rooms—just quick, virtual visits that fit seamlessly into her schedule.
Medications were also no longer a hassle. Instead of picking up treatment from a distant pharmacy, the study team delivered the clinical trial therapy directly to Sarah’s home. If she had any concerns or experienced side effects, Sarah could quickly reach out to the research team via a secure messaging platform or by direct phone contact.
In Sarah’s case, the wearable wristband was just one piece of the puzzle. She also used a smartphone app to log her symptoms and medication use. This user-friendly app allowed her to see daily reminders and easy-to-navigate screens. It felt like a natural part of her routine, and knowing that her data was helping to advance medical research gave her a sense of purpose.
Meet Caleb: A Patient’s Story
Caleb, a hypothetical man who is a husband and grandfather, is a bus driver and paid hourly. His available time off is limited to two weeks a year with pay. He has been managing his type 2 diabetes for years. When his doctor mentioned a new clinical trial for a groundbreaking diabetes treatment that would change his care routine, he wasn’t sure. Caleb had always been diligent about managing his diabetes; still, monitoring blood sugar levels with finger pricks and administering insulin through a syringe could be exhausting. The trial offered him a chance to try something new—a wearable device that monitored his glucose levels and administered insulin as needed.
The idea of frequent trips to a research site seemed daunting, especially with his limited time off that he would rather use for time with his wife and grandchildren. That’s when his doctor explained that this trial was different—a hybrid Decentralized Clinical Trial (DCT), allowing him to participate without disrupting his daily life. For Caleb, this meant he could take part in the trial through his local doctor’s office, located just a few miles from his home in the suburbs, rather than traveling to a distant research center.
How a Hybrid DCT Fits into Everyday Life
After enrolling, Caleb received a small, discreet device that he could comfortably wear on his arm. This device continuously monitored his glucose levels and automatically administered insulin when necessary. The best part? Caleb’s study visits to his doctor’s office were significantly reduced compared to a more traditional clinical trial. Instead of frequent visits for blood tests and injection medication adjustments, Caleb visited his doctor once a month at a convenient time for him, and the medication was adjusted automatically using the new device. During these visits, his doctor reviewed the data collected by the wearable device, ensuring it was functioning properly and everything was on track for his care needs.
Staying Connected with the Study Team
Even though Caleb didn’t need to visit the research site frequently, he never felt disconnected from the study team. They kept in touch with him regularly through phone check-ins, asking how he was feeling, addressing any concerns, and ensuring he was comfortable with the wearable device. He spoke to them during his lunch break so he could continue his work schedule as normal. This ongoing communication made Caleb feel supported, knowing that help was just a phone call away if needed.
Convenience and Care Combined
Caleb appreciated the flexibility that the hybrid DCT offered. On days when he didn’t have an appointment, he could focus on his family, work, and his own interests without the constant need to manage his diabetes manually. The wearable device handled the details, and Caleb enjoyed the peace of mind that came with knowing his glucose levels were under control.
The device itself was easy to use. Caleb’s doctor had walked him through the setup during his first visit, and the device automatically synced with a smartphone app, providing real-time updates and alerts. If something went wrong, like a low battery or a need for a manual adjustment, the app would notify Caleb immediately, as well as the study team who then contacted him with instructions.
What to Expect as a DCT Participant
If you’re considering joining a DCT, you might wonder what your experience will be like. Here’s what you can expect:
Convenient Access: Most trial activities occur in your home or at a nearby location. Whether it’s a local clinic, healthcare system, pharmacy, or even your living room, the trial fits into your life, not the other way around.
Frequent Communication: You’ll maintain regular contact with the research team through virtual visits, local visits close to home, phone calls, or secure messaging. This communication ensures you’re always in the loop and can ask questions whenever they arise.
Personalized Support: The study team guides you every step of the way. From setting up your wearable devices if needed for the study, scheduling your visits via video calls or in-person at your local healthcare office, to answering questions about the trial, you’ll have a dedicated support system at your fingertips.
Less Travel, More Participation: By reducing or eliminating the need for in-person visits or long travel times and expenses to faraway locations, DCTs make it easier to stay involved. A reduced burden on you means fewer disruptions to your daily routine and more time to focus on what matters most: your life.
Advanced Technology: You might use wearable sensors, smartphone apps, or remote monitoring tools. The design and use of these technologies are user-friendly and integrate smoothly into your life.
The Changing Landscape of Research
Sarah’s and Caleb’s hypothetical stories are examples of real-world DCTs changing the clinical research landscape. By bringing the trial to the patient, DCTs allow more people to participate in groundbreaking studies, regardless of location or lifestyle. For all clinical trial participants, this means having a voice in the future of medicine without sacrificing the present.
If you’re considering joining a clinical trial, a DCT could be the perfect fit. It offers the chance to contribute to medical research on your terms, with the support and flexibility you need. You can play a pivotal role in advancing healthcare, all while continuing to live your life to the fullest.