Understanding Decentralized Clinical Trials: Research That Comes to the Patient
Imagine being in a clinical trial without ever stepping foot in a hospital. Study visits happen by video call. A nurse comes to your home to draw blood. Medication is delivered to your door. A smartwatch sends continuous health data to the research team. This is not a distant vision of the future. It is the reality of decentralized clinical trials, and it is changing who can access clinical research.
The Clarity Clinical Solutions video on decentralized trials tells the story of that change. A decentralized clinical trial, or DCT, replaces the traditional model where patients must travel to a physical site for every visit. Instead, most study activities happen where the patient is: at home, at work, or in their community.
The pandemic was the tipping point
Decentralization existed before COVID-19, but the pandemic forced the issue. The video cites the shift in plain numbers. In 2019, fewer than 5% of trials had any decentralized elements. By 2022, over 70% of new trial designs included at least one. That is not a temporary adjustment. It is a permanent transformation of how clinical research is conducted.
What makes a DCT work
A decentralized trial combines several components. Telemedicine platforms enable secure video consultations where investigators review symptoms and assess side effects. Home health services send mobile phlebotomists and nurses to patients' homes for blood draws, ECGs, and vital signs. Direct-to-patient drug delivery ships study medication in temperature-controlled packaging, with automated refill scheduling and return kits for unused product. Digital data collection through ePRO apps and wearable devices captures health information continuously between visits.
Most DCTs are actually hybrid. Some in-person visits remain for procedures that cannot be done remotely, like imaging scans or complex laboratory tests. Fully decentralized trials exist but are rare, and they are usually reserved for observational studies.
The difference from a traditional trial
In a traditional site-based trial, the patient travels to the clinic for every visit. In the United States, the average round trip to a trial site is over two hours. Patients miss work, arrange child care, and pay for parking. Data is collected only during clinic visits, which are brief snapshots that may not reflect the patient's real day-to-day experience.
In a decentralized trial, most visits happen from home. The patient connects with the study doctor by video. A mobile phlebotomist comes to them. Wearables collect data between visits. Geographic distance stops being a barrier to participation. The video's numbers make the case: the decentralized trial market is estimated at over $10 billion, the number of trials with DCT elements has tripled since 2020, over 70% of sponsors are investing in DCT capabilities, and patient retention in decentralized trials is roughly double that of traditional trials.
Why patients and sponsors like it
For patients, the advantages are obvious. No travel, less time off work, and the ability to participate from home. This matters most for people who were previously excluded from research entirely: rural residents, people with disabilities, caregivers who cannot leave dependents, and workers who cannot miss multiple days a month. Patients in rural areas, who make up about 25% of the US population, are three times more likely to participate in a decentralized trial than a site-based one, according to the video. For them, decentralization is not a convenience. It is the difference between being able to participate and being excluded.
Sponsors benefit too. Enrollment is faster because geography no longer limits recruitment. Retention is higher. And more diverse patient populations produce more generalizable data. That combination, better retention and better data, is a rare win-win in clinical research.
What regulators say
Regulators have moved in step. The FDA issued its first guidance on decentralized clinical trials in 2021, with a major update in 2023 covering telemedicine informed consent, use of electronic health records as source data, remote monitoring, direct-to-patient shipment of investigational products, and home health services (FDA: Decentralized Clinical Trials for Drugs, Biological Products, and Devices). The draft revision of the ICH GCP guideline, E6(R3), published in 2023, integrates decentralized principles throughout, shifting oversight from site-centric to activity-centric (ICH Efficacy Guidelines). The video also flags a practical wrinkle: in the United States, telemedicine providers must be licensed in the patient's state, which complicates national programs, while cross-border telemedicine within the European Union is comparatively straightforward.
The challenges
DCTs are not frictionless. The digital divide means older patients, lower-income households, and people in areas with poor broadband can be left out, the very patients who might benefit most from remote access. Home-collected blood samples may show more variability than clinic-performed procedures, so sample handling protocols need to be robust. And coordinating telemedicine, home health visits, and direct-to-patient drug delivery across states, time zones, and holiday schedules is enormously complex. The video's assessment is fair: these problems are solvable, but they require investment and careful planning.
Running a DCT also demands serious infrastructure. Telehealth must be HIPAA-compliant and integrate with the trial's electronic data capture system, supporting e-consent, scheduling, and reminders. Logistics companies coordinate networks of home health nurses across states. Central data platforms pull everything together, telehealth, home health devices, wearables, ePRO, drug tracking, and electronic health records, into a single picture, even though there is no single physical site where the data comes together.
What a DCT day looks like
The video sketches a typical day for a DCT patient. At 8 a.m., a phone notification prompts a two-minute symptom diary. At 9 a.m., the smartwatch uploads sleep and activity data. At 10 a.m., a fifteen-minute video visit with the study doctor. At 2 p.m., a courier delivers the next month of medication. At 4 p.m., a home health nurse draws blood and checks vitals. Total time spent, about an hour. Total travel, zero. A traditional trial visit, by contrast, typically takes three to five hours including travel.
The bottom line
Decentralization is not a COVID-era trend or a niche approach for simple studies. It is the permanent evolution of how clinical trials operate. The question is no longer whether trials should include decentralized elements, but how to do it well. For patients who could never reach a trial site because of distance, disability, or caregiving responsibilities, decentralization is a gateway to research that was previously closed. The future of clinical research is not about bringing patients to the research. It is about bringing the research to the patients.
This article is based on the Clarity Clinical Solutions video "Understanding Decentralized Trials in Clinical Trials." Watch it here: Understanding Decentralized Trials in Clinical Trials
References
- Clarity Clinical Solutions — "Understanding Decentralized Trials in Clinical Trials" (framework for this article). https://www.youtube.com/watch?v=JkoXZ1iVq20
- FDA — Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices (May 2023). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices
- ICH — Efficacy Guidelines, including ICH E6(R3) Good Clinical Practice draft revision with decentralized trial principles. https://www.ich.org/page/efficacy-guidelines
- ClinicalTrials.gov — Registry of clinical trials worldwide. https://clinicaltrials.gov/