With COVID-19 continuing to disrupt our lives and limiting people’s movements, carrying out clinical trials has been particularly challenging over the past year. This comes on top of the hurdles typically faced in traditional trials, especially regarding participant recruitment and retention.
Trials@Home aims to clear the way for more Remote Decentralised Clinical Trials (RDCTs) to take place in Europe, in which patients can participate without leaving their homes. To achieve this, the project’s ambition is to reshape the design and operation of clinical trials, issuing recommendations on the conduct and implementation of such trials, piloting new approaches, and developing adequate technologies and tools.
On April 21 and 22, the Trials@Home consortium held a virtual biannual meeting, gathering its 31 project partners for two afternoons of presentations and discussions on the project’s progress and the future of clinical trials in Europe.
After the first set of recommendations on best practices in RDCTs was published, the design of the pilot study is now being developed. Its aim is to demonstrate that RDCTs can be as effective as traditional clinical trials. Type 2 diabetes is the therapeutic area that will be studied during the pilot.
The latter will start in 2022 and be conducted in several EU countries that will be selected following the recently completed EU mapping of regulatory frameworks for clinical trials. The pilot is also made possible by the ongoing evaluation and procurement of the required technologies, which is key for a successful Remote Decentralised Clinical Trial. Meanwhile, the project has been probing the need for education of people living with diabetes and other conditions, principal investigators, and healthcare practitioners on RDCTs.
As part of the Trials@Home project, IDF Europe is working to make the voice of people living with diabetes ring louder, following the “Nothing About Us Without Us” moto. Our conviction is that people living with diabetes should always be involved as key partners in daily care and research, since they are de facto experts in the management of their condition.
For this reason, IDF Europe has been central in setting up and managing the Patient Expert Panel for Trials@Home, a group of people living with diabetes relaying their experiences and needs to the project coordinators. As an example of such input, on the second day of the meeting one of our Patient Experts took part in a panel session on keeping the RDCT model going after COVID-19.
Trials@Home is an EU/EFPIA Innovative Medicines Initiative [2] Joint Undertaking.
