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Author: ClinEdge Staff

Feb 09, 2022 •
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Participating in a clinical trial takes time. For many patients, that commitment becomes too much when combined with the hours it takes to travel to and from clinical research sites. Decentralized trials pose a potential solution to this issue, but these models are not without their own challenges.

In addition to loss of clinical trial site revenue, here are four of the most common challenges decentralized trials present and how Elligo Health Research® overcomes them.

Participant Accessibility

When running a virtual trial we must think about the participants’ access, mainly if they have access to key decentralized clinical study components such as smartphones, Wi-Fi, computers, or other tech devices. Patients without access to reliable internet or those who lack a basic understanding of technology will face significant difficulties in effective research participation.

Hybrid clinical trials, meaning studies run both on- and off-site, are effective alternatives to solely relying on technology and patient’s technology confidence. Hybrid models give patients the flexibility to have their data collected in person at a healthcare office, pharmacy, community center, or at home, depending on their needs and preferences. Traditional, site-based clinical studies also solve this problem, especially when paired with Elligo’s suite of site solutions.

Elligo’s suite of site solutions offers comprehensive services to support patients in both hybrid and traditional trial models. For example, Elligo provides a unique blend of patient-centric solutions to improve patient compliance, retention, and overall experience. Enrollment Solutions further enhance the patient experience and supports study completion by managing patient and caregiver transportation needs.

Compliance

When participants lack access to key trial components and support, the trial will be at a higher risk for protocol deviations. As participants enter and submit their own trial data from home, work, or school, they may use the device wrong, record their data incorrectly, or forget to record their data all together.

Thorough training on how to use the required technology could help in some cases, but allowing patients to check into a clinical research site for data collection would best help prevent protocol deviations. Again, Elligo’s Site Solutions provides an effective, efficient solution. Our enrollment solutions offer patient compliance and oversight services that streamline the trial process and enhance compliance to protect data integrity, and make it easy for patients to get to the research sites for check-ins and data entry.

Medical Oversight

It’s no secret that the decentralized trial market is growing. In fact, it’s expected to grow by 15% through 2027. This rapid growth has left research sites worrying that they will be cut out of the study process altogether, especially since completely site-less trials raise serious protocol and medical oversight concerns.

Decentralized trials may be the way of the future, but they don’t have to mean fully site-less. Adapting to this “new normal” with hybrid trials is the best way to prevent oversight, and Elligo’s IntElligo® Research Stack technology significantly eases that adaptation. Easy for sites to use, IntElligo ensures data integrity with end-to-end integrated data support from patient ID to study close.

Technology

When it comes to decentralized trials, both site staff and participants will most likely have to learn and implement new technology, leading to increased costs and delays as well as compliance issues. Site staff schedules only allow limited time for learning new software, but the trial start may be delayed if the staff is not appropriately trained. Study participants may be expected to operate wearable devices, smartphones, or computer applications; but if they do not feel comfortable with the technology, they might use the devices incorrectly and negatively impact data collection.

Enjoy a more seamless transition to hybrid trial technology for site staff by using Elligo’s user-friendly, easy-to-learn technology platform. As for participants, hybrid trial models help ease the use of technology as site staff will be able to check if patients are using the devices correctly and answer any questions they may have. Patients are further supported in their technology use by Root, Elligo’s digital study buddy. Like “Alexa” or “Siri” for clinical research participants, Root provides 24/7 study concierge support, surveys, chats, links, and consents, as well as scheduling assistance and appointment reminders to engage, educate, and retain patients.

The Elligo Way

Elligo provides access to the best healthcare experts, patients, and research technologies. As the ultimate healthcare-enabling research organization, we maintain the integrity of the trusted patient and physician relationship, leveraging electronic health records to bring more patients clinical research as a care option.

Whether in traditional or hybrid clinical research models, Elligo is focused on providing the best approach and treatment for each patient. Contact us today to learn more about our supportive services.

 
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