In the future, patients could take part in clinical trials from the comfort of their own home, avoiding the inconvenience of regular clinic visits.
High drop-out rate
In a conventional clinical trial, patients have to make regular trips to the clinic for check-ups to monitor their condition. Many patients are understandably put off by the distance to the clinic and how often they would be expected to make the trip, and some patients who initially join trials drop out for logistics reasons.
The new IMI project Trials@Home aims to address this issue by exploring the potential of digital technologies for use in ‘remote decentralised clinical trials’ (RDCTs). Digital technologies and wearable devices mean it’s now possible to assess patients remotely – while they’re at home, or going about their daily lives. If used during clinical trials, they could dramatically reduce the number of times patients are expected to visit the clinic.
Conventional vs unconventional trial experience
The project team will develop and test methods to streamline data collection as well as patient recruitment and retention. They will also discuss RDCTs with patients as well as regulators, payers, health technology assessment bodies (HTAs) and ethics bodies, to ensure that the project outcomes can be implemented. At the heart of the project is a study in which one group of patients will have the conventional clinical trial experience with regular clinic visits; a second group of patients will participate completely remotely; and a third group will follow a partly conventional / partly RDCT approach. The project will use the results of this study to identify which approaches are best for patient satisfaction, data quality and other parameters.
If successful, RDCTs could make it easier to recruit and retain larger numbers of patients, including people from groups that are often under-represented in trials. Furthermore, as data collection would be more or less continuous, the results would be more reliable and more representative of the real world.
Trials@Home will last for 5 years and has a budget of EUR 38 million; half of this comes from Horizon 2020 via IMI, and half comes from the EFPIA companies in the project. The 31-strong consortium includes universities, large pharmaceutical companies, medical device companies, small and medium-sized enterprises (SMEs), and patient groups.
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