Introduction. Sponsors of clinical trials propose variations of home visits and virtual contact points with the patients instead of visits at the clinical sites, as well as other digital and remote solutions.
The objective of the study was to search and analyse the experience and practice of European countries on applying decentralized elements and a hybrid approach of conducting clinical trials’ activities and procedures, as well as to establish the applicable rules and regulation. Material and methods. A questionnaire survey was conducted among European countries in the period December 2020 – February 2021, by email communication.
Results. In most of the countries, it was not forbidden, and respondents indicated the opportunity of medical specialists to help patients at their home. 37.50% of the countries indicated that the applicable legislation cannot be related to the medical or clinical trials legislation or national commercial law but “Other”. Based on the practice, all or some of the activities can be done as a home care. 68.75% responded negatively to the application of the “site-less” model, but 81.25% considered that the combination of on-site and home visits can be better than only visits at sites.
Conclusion. Based on this research, the implementation of decentralized elements in the clinical trials in Europe is often based on a case-by-case evaluation only. Notwithstanding the application of various national requirements and acts, they are either fragmentary, or not specifically applicable for such cases.
Keywords: patient-centred, home visit, clinical trial, European countries.
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Address for correspondence:
Veska T. GERGOVA
Bulgarian Drug Agency, Sofia, Bulgaria
Address: 8, Damyan Gruev str., Sofia, 1303, Bulgaria
E-mail: vesigergova@gmail.com; Phone: +359899100742
