Research
According to De Jong, there are still many questions about conducting home studies. De Jong: “For example, it is unclear whether the data collected at home is as reliable as the data collected in the hospital. In addition, it is not known which patients would like to participate in a home study or prefer a study with periodic hospital visits.”
Within the Trials@Home project, research institutes and companies try to answer these questions. A group of researchers from Utrecht University is involved in this project, specifically in mapping the regulations and the perspective of supervisors on home studies.
The study that is central to this project, called RADIAL, is being led by the University Medical Center Utrecht with Mira Zuidgeest as principal investigator. This study has recently received regulatory approval from Denmark, Germany, Italy, Poland, Spain and the United Kingdom, where the study will start shortly.
Within RADIAL, an existing drug is used to explore the concept of home studies. People living with type 2 diabetes can participate in the RADIAL study (i) completely at home, (ii) in a hybrid form, (iii) or in the ‘traditional way’ through hospital visits. The results are then compared between the three options. In addition, research is being done in Utrecht into the preferences of people living with type 2 diabetes and the way in which they want to participate in clinical studies.
De Jong: “The insights gained from the Trials@Home research will help to assess the reliability and usability of data from home studies. In this way we contribute to more patient-friendly and representative studies in the future.”