Clinical studies are necessary to develop new medicines and medical devices and to learn more about the use of existing products. In the European Union, about 4000 clinical studies start annually. However, not all patients who would like to participate can easily do so. De Jong: "Often, there are strict requirements to select study participants. In addition, potential participants may decide not to participate due to personal considerations or circumstances."
For example, participants have to visit the participating hospital regularly for blood draws, to fill out questionnaires, or for other measurements. Moreover, the participating hospital is not always the hospital closest to the participant. As a consequence, a proportion of the potential participants that meets the criteria to participate, may not be able to join the study. This could, for example, be the case for people with full agendas, people with impaired mobility, or people who live far from the participating hospital.
Together, these factors may lead to some studies being unable to find sufficient participants and/or participants who are not representative. This is important because study results may therefore not reflect clinical practice.
More accessibleBy moving clinical studies - or elements thereof - to participants’ homes, studies can be made more accessible. Participants no longer need to visit the hospital for study-related activities, or at least not that often. De Jong: "More and more measurements can be done remotely. For instance, information can be collected using smartwatches or by filling out questionnaires via an app. By performing studies at participants’ homes, participant diversity may increase because patients who previously were not able to participate - because of practical concerns - may now be able to do so."
Recent European recommendationsPerforming clinical studies completely at the homes of participants is still uncommon. This is particularly true for studies in which new medicines are tested. Before they can start, studies with medicines are thoroughly assessed by regulators, who must approve these studies to guarantee the safety of the participants. During a study assessment, authorities have to evaluate whether performing studies at home may affect the safety of the participants and the study results - positively or negatively - and whether measures are needed to minimize this impact.
European authorities have recently published recommendations for home studies. According to De Jong, this is an important development. De Jong: "It provides more clarity about the assessment of home studies to investigators and pharmaceutical companies. Consequently, more home studies may be performed in the future, which would also provide new opportunities to look into the disadvantages and advantages of these studies."
Through the Trials@Home project, we contribute to future patient-friendly and representative studies.
Amos de Jong
There are still many questions regarding home studies. De Jong: "It is, for example, unclear whether the information collected at home is as trustworthy as information collected at the hospital. Besides, it is unclear what type of patients find it comfortable to participate in a home study, and what type of patients would prefer studies with recurrent hospital visits."
Within the Trials@Home project, research institutions and companies try to answer these types of questions. A group of researchers from Utrecht University is involved in this project and investigates the regulations and the perspectives of the authorities on home studies.
The central study within the project, the RADIAL study, is led by the University Medical Center Utrecht, with Mira Zuidgeest as the principal investigator. This study has recently received approval from the authorities of Denmark, Germany, Italy, Poland, Spain, and the United Kingdom, where the study will start in the near future.
In the RADIAL study, an existing medicine will be used to test the concept of home studies. People living with type 2 diabetes can participate (i) from home, (ii) in a hybrid approach, (iii) or according to the ’traditional approach’ by visiting the hospital. The results will be compared between the three options. Also, in Utrecht, another research project investigates the preferences of people living with type 2 diabetes on how they would like to participate in a clinical study.
De Jong: "The outcomes of the Trials@Home project will help to assess the reliability and usability of results from home studies. This way, we contribute to future patient-friendly and representative studies."
Do you have questions or comments after reading this article? Feel free to contact Amos de Jong via e-mail ( firstname.lastname@example.org ). If you would like to receive more information about (participating in) the patient preference study among people living with type 2 diabetes, please contact Julia Kopanz ( email@example.com ).
The Trials@Home project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.