Europe: EMA Releases New 'Practical Guidance' on Foreign Clinical Trials
The European Medicines Agency (EMA) yesterday (16 April) published guidance, in the form of a final reflection paper, on ethical and good clinical practice (GCP) aspects of clinical trials conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorization applications to the EU regulatory authorities.
The paper, which enters into force on 1 May 2012, is intended to strengthen existing processes to provide assurance to regulators and stakeholders that foreign clinical trials meet the required ethical and GCP standards.
The paper stresses the importance of independent local ethics committees and of obtaining consent from clinical trial subjects.
It discusses key issues including those arising from consent the comparator used in a trial (active or placebo) or access to treatment after a trial, especially in the context of the vulnerability of trial subjects.
Read more: