Decentralized trials are defined by the FDA as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. These trials can be fully DCT (the study participant can participate in the entire clinical trial from their home or other convenient location) or hybrid DCT (combine the use of both sites and remote locations and is currently the most common type of DCT being implemented). The most significant difference between a site-based and a decentralized trial is that data capture for the DCT most often occurs outside of the site visit.
Graphic adapted from Nidhi Bajpal, Decentralized Clinical Trials: A Data Scientist’s Perspective
The aim of decentralized trials is therefore to encourage patient participation by reducing or eliminating the need for travel to sites. These trials are conducted remotely, with subjects needing far less, or no time at the traditional clinic or hospital. This is only possible through the advancement of technology, driving an increasingly mobile user landscape than ever before.
The industry has been slow to adopt the decentralized paradigm, but the recent pandemic has brought this into focus as the industry struggles to maintain trial continuity. Moving to a virtual and direct-to-patient approach is the new norm, with over 79% of CROs and sponsors declaring an increase in their use of decentralized trials in 2020 alone.
There are significant benefits of DCT trials to both subjects and sponsors alike. They drastically reduce the patient burden of scheduling visits and arranging travel to and from clinical sites – collecting the necessary data from the subject wherever they are. Subjects tend to become more knowledgeable, informed and engaged through greater autonomy, enabled by technology. They can report symptoms in real-time via an app, researchers can send out reminders for study activities, thus keeping subjects engaged and ensuring protocols are adhered to. The resultant decrease in travel and wait times further enhance patient satisfaction.
For the sponsors, decentralized trials bring an immediacy to the data, allowing greater safety oversight and standards of care, whilst letting them expand to areas and geographies previously unavailable to more traditional trial protocols – connecting subjects to trials on a global scale. This not only increases the pool of potential subjects, increasing the rate of trial completion, but also increases patient recruitment as less travelling is involved to site.
Image adapted from “Decentralized Clinical Trials in 2020: A Global Survey”, PharmaIntelligence
To move the point of care out of the clinic, sponsors, CROs and sites need novel technology solutions as an alternative to traditional site-centric trials. One of the main challenges and barriers to adoption of DCT trials cited by the industry is the lack of suitable technology.
| One platform | Multi-modal data collection | Real-time 24/7 data |
|---|---|---|
| Have full and continuous oversight of all your data: collect, manage, visualize, and analyze your data from portfolio to patient level. | Capture data your way: use any mix of eSource, EDC or Home Visit in the same study and utilize multimedia for remote monitoring and novel study endpoints. Third party data can be uploaded for rapid data ingest and integration. | Collect, query, clean, visualize and analyze ALL your clinical data in real-time, in one platform, with a single representation of the data. Encapsia is available 24 x 7 for the entire study team with no end user downtime for mid-study design changes or maintenance. |
| Site centric | Visualizations | Data quality |
|---|---|---|
| Fast response times, intuitive workflows, and navigation with easy-to-use entry options all contribute to less time in the system, freeing sites to focus on what really matters – their patients. | Powerful, configurable tools at your fingertips. Your data, where and when you want it, in real-time. | Clean data instantly with entry validation checks, saving time and money. |
Here at encapsia, we have long championed the need for more efficient and effective clinical trials and offer encapsia as the solution. Our innovative platform provides an agile, revolutionary way to support the adoption of decentralized clinical trials.
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