The rise of decentralised trials and why it’s important for modern clinical trials
What are decentralised trials?
Decentralised trials limit the burden of trial participation by reducing or eliminating the need for participants to visit the research site. It involves making adjustments that put the patient first. A trial can be 100% decentralised, where the patient and clinician never physically interact, or it can have remote elements but some site visits are still needed. Not all trials can be 100% decentralised, after all you can’t perform an MRI on someone at home, at least not yet.
Methods of decentralisation
The two primary methods of decentralisation are:
- Digital approaches
- Non-digital approaches
Digital approaches to decentralisation
Digital approaches encompass a wide range of possible solutions to decentralise a trial and reduce the number of in person visits needed. They can also offer additional advantages by proving the opportunity to capture additional information that otherwise would not have been possible, a win-win situation for patient and researchers.
Digital approaches therefore can be broken down into 2 categories:
- Tools for improving the traditional clinical trial process
- Novel tools for reimagining the clinical trials process
Tool for improving the clinical trial process
Digital tools in this category have become more standard in recent years and includes digital platforms that replace what was traditionally paper-based. For example:
- Digital platforms to capture consent (eConsent)
- Digital platforms which replace the paper based case report form (CRF); appropriately named electronic case report form (eCRF)
Digital tools can also include tools that offer benefits that weren’t possible any other way, for example smart dosing . Smart dosing’ is where digital tools are used to try to improve drug and therapy adherence. App’s that alert the participant they need to take a dose perhaps, or a Mems device that can monitor adherence.
Novel tools for reimagining the clinical trials process
These tools are unlike our previous category, for improving the traditional clinical trial process, are a new way to deliver trials and gather data. Consequently, tools that fall into this category are novel in comparison and challenge the traditional way we have been running clinical trials. Tools in this category can allow researchers to collect data that would otherwise not be practical or accessible any other way.
Examples of digital tools in this category are:
- Digital tools that act as an intervention, for example a guided meditation app to reduce cardiac events perhaps, or an implantable loop recorder.
- Digital tools that serve as an alternative endpoint, for example digital biomarkers
Digitization of our healthcare system is not new
It’s important to point out that the digitization of our healthcare system is not new. Patient medical records and now being held in databases rather than filing cabinets. Appointments are being increasing booked though online portals than by calling reception. Virtual wards are a thing in almost all hospitals. And the list goes on.
It is the reimagining of how technology can be used within the context of clinical trials which is new, and the silver lining of the COVID-19 pandemic is that the implementation of such technology has been accelerated by necessity.
Non-digital approaches to decentralisation
Of course, digital tech isn’t the only way to decentralise a trial, but perhaps it’s the best way to do so at scale. Non-digital approaches include homecare companies which bring the care to the patient in comparison to asking patients to travel to a clinical site. The clear advantage here is the reduced burden on this participant, which is one of the primary advantages of decentralisation
Conclusion
One of the biggest issues with clinical trials is related to issues with recruitment. Modern trials need a patient centred approach to reduce the burden on patient participation and decentralisation is one way to contribute to such patient centric approaches. Decentralisation of course isn’t perfect, and whilst we haven’t covered the disadvantages here, know that no approach is perfect. All approaches have advantage and disadvantages but the benefits to the participant must not be overlooked.
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