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