10 Sep What is a decentralised clinical trial?
Medicine has changed. Digitalisation has become the most powerful area in this field. It all started with Covid-19 and it has now spread to clinical trials. From our medical translation agency, which has extensive experience in translating clinical trials, we want to explain what a decentralised clinical trial is.
The approach of moving patients to the clinical centres chosen for their trials has always been something of a problem for companies. The advent of telemedicine, however, has allowed some clinical trial participants to be assessed at home, which has become a key factor in the development of this research.
What a decentralised clinical trial looks like
A decentralised clinical trial integrates modern digital health technologies – such as mobile devices, mobile apps, remote monitoring devices and online social engagement platforms – into the study design.
This can allow patients to be monitored at home rather than having to travel and it can also enable continuous real-time data collection of endpoints during the course of a trial participant’s daily life, rather than periodic data collection during site visits, which can provide only a snapshot of the important health information.
The idea has been around for years and has been talked about by the companies offering these services, but most CROs and biopharmaceuticals preferred the old approach. Of course, this virtual trial model does not work for everyone: some participants will need to be in a hospital setting for certain trials and digital technologies can only go so far.
Still, for many, being able to take part in a trial while at home is a big advantage, reduces costs, and can boost recruitment and retention, some of the biggest issues facing CROs and biopharma.
With Covid-19, the FDA was quick to announce new guidance saying that, where possible, many trials should be moved to a virtual model to keep research moving forward. It is worth remembering that even if the clinical trial being conducted is decentralised, medical translations are still necessary to disseminate the results of this research.