Trials@Home is piloting remote decentralised clinical trials, and they’re seeking out the technology to make it happen
Covid-19 has caused clinical trials all over the world to be slowed or even stopped, but it’s also given us a glimmer of what clinical research might look like in the future. Researchers and health professionals have been thrown headfirst into the world of telemedicine, mobile technologies and artificial intelligence to carry out remote care and monitoring and more, helping to bring into view what many believe will be the future of clinical research – remote and decentralised clinical trials (RDCTs).
RDCTs can help attract (and keep) trial participants because they cut down on scheduling and travel headaches, allowing people to be observed from the comfort of home. Researchers get to expand their studies to include people who would be hard to sign up otherwise – taking a trial global, for example, while reducing costs and other burdens on clinical trial sites (to read more about the benefits and challenges of RDCTs, check out the project About section.
Before RDCTs become the norm, though, there are some issues to be addressed, standards to be set, and best practices to be drawn up, all of which are being worked out in the Trials@Home project. The project chose diabetes as the basis for a pan-European pilot that will pit RDCTs – both full and ‘hybrid’ - against traditional clinical trials, with particular focus on what works best for patient satisfaction and ensuring the best data quality. The pilot is the real meat of the Trials@Home project, and the partners expect the results to feed a concrete set of recommendations that drug companies can look to when using digital technology to conduct their own RDCTs in the future.
To carry out the pilot, they first need to round up the right technology. They’ve launched a call for the vendors that can supply the tools necessary to carry out the trials from A to Z; that includes everything from patient-side technologies (e.g. a platform for videos and digital communications, calendar downloads and syncing, visit alerts etc.) to clinical-side requirements (e.g. an operational platform for real-time oversight dashboards, compliant with data privacy laws etc.). They are also seeking the technology that will actively and passively collect data such as insulin dosing or glucose monitoring devices and any other relevant wearables, sensors and apps.
Trials@Home have categorised the type of technology they’re looking for into so-called ‘Basic Building Blocks (BBB),’ each BBB with its own set of key functionalities. The most suitable technologies will be selected on the basis of their ability to carry out these key functionalities, and will be funded by the project.