Recommendations on

Assessment & Approval

Regulatory and ethical engagement was a cornerstone of Trials@Home, given the implications of this innovative model. In this theme, we examine ethical considerations, the regulatory landscape, and the level of awareness among HTAs across Europe.

Overarching ethical considerations

Overarching ethical considerations

All clinical trials require ethical review, including DCTs.  However, the regulatory and ethical review system was designed for conventional (site-based) trials. To fully realise the promises of DCT approaches, the ethical context needs to be aligned …

Health Technology Assessment awareness

Health Technology Assessment awareness

Health technology assessment (HTA) bodies are responsible for evaluating new health technologies to support reimbursement decision-making in Europe. As data from DCTs may be used for clinical or economic evaluation …

EU Regulatory landscape

EU Regulatory landscape

Prior to the implementation of the Clinical Trials Regulation (EU No. 536/2014), clinical trials in the EU were governed by EU directives (2001/20/EC, 2005/28/EC) and national laws, with variability across Member States (MS). In 2022, the Clinical Trials Regulation (CTR) became mandatory…