Assessment & Approval

Our Recommendations

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…