A Breakdown of Clinical Trials: Fully Decentralised or Hybrid | KORE

Decentralised clinical trials (DCTs) are not a new concept in the healthcare space. In fact, DCTs were first registered and recorded in the year 2000, with approximately 2,100 studies in the first year. Since then, the number of registered studies has steadily increased year-to-year; however, there was a sizeable jump from 32,514 total studies in 2019 to 36,722 total studies in 2020 due to the COVID-19 pandemic. 

More recently for the European Union, as of 31st January 2023, all initial clinical trial applications in the EU/EEA must be submitted through the Clinical Trials Information System, to 'support the undertaking and oversight of clinical trials in the European Union (EU) and European Economic Area (EEA).' This is to further support large clinical trials in multiple countries for the benefit of patients and medical innovation.

Healthcare professionals continue to use this practice with their patients to improve patient engagement and recruitment. As of July 2023, there are a total of 459,195 registered clinical trials. Hospitals and clinics are increasingly leveraging connected devices for clinical trials, and market research indicates that the adoption of these technologies will continue to grow.

So, what exactly are decentralised clinical trials? DCTs include virtual home healthcare services, direct to patient drug shipments, telehealth mobile applications, and more. The purpose of DCTs is to reduce site visits for patients through the use of Internet of Things (IoT). There are two types of models: fully DCT and hybrid – and the names suggest what the intent is.

Full DCTs are 100 percent remote with no clinician-to-patient interaction. This model uses the same type of mobile and medical devices as hybrid trials, but additionally they rely on recruitment and retention platforms, e-visits, and video dosing regimens for patient interaction and engagement. Hybrid models include elements of both traditional in-person visits and fully online/remote visits.

A primary differentiator between hybrid and clinical trials is the use of handheld mobile devices, including electronic diaries for eCOA and ePRO, and connected medical devices such as blood pressure cuffs, blood glucose meters, pulse oximeters, and more. The difference between Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-Reported Outcome (ePRO) is that ePRO systems are a type of eCOA. Clinical trial patients often use eCOA system technologies on mobile devices to remotely send their ePRO symptoms and experience directly to site staff.

The Benefits of IoT-Enabled Clinical Trials

Clinical trials through IoT deliver an abundance of value for both the patient and healthcare provider:

• Accurate data monitoring – IoT can help improve the quality of patient data collected by healthcare professionals. Devices are able to sync with one another more effectively, resulting in fewer technical errors when sending information directly to clinicians.
• Improved patient experience – In tradition healthcare visits, patients would have to visit their doctors and clinics onsite to receive treatment, prescriptions, and more. Virtual DCTs can make healthcare more accessible to everyone. The online screen barrier between the patient and doctor offers limited to no exposure with one another, creating less risk of viral transmissions.
• Real-time communication – Due to the online nature of DCTs, patients are given access to a dashboard/portal to communicate and interact with their care provider to report any symptoms or concerns.
• Enhanced patient recruitment – Utilising IoT to power hybrid or full DCTs creates greater accessibility and flexibility to clinical trials and allows teams to include patients that otherwise would not have been geographically able to participate.  Having greater geographies also allows study to improve the diversity of patients that participate, create better trails and deeper, more effective insight.
• Increased patient compliance – Patients require simple, work out of the box solutions. By simplifying the process and reducing/eliminating technology and connectivity roadblocks, patient participation will increase because we have helped remove the “friction” many feel when the effort to participate exceeds their interest in participating.

Get Started with KORE

The future of connected health is here and now. KORE offers comprehensive services and solutions, such as mobile device management (MDM), and works with global healthcare providers to deploy connectivity in over 165 countries. Are you ready for decentralised clinical trials? Contact us to schedule your readiness assessment here!

And to learn more about the marketplace, benefits, and use cases for DCTs, download our eBook, “Decentralised Clinical Trials: A Guide to Connected Health Telemetry” here.