EMEA moves to boost controls over non-EU clinical trials
EMEA is planning to increase controls on clinical trials staged outside the EU and North America.
EMEA is planning to increase controls on clinical trials staged outside the EU and North America.
The EU agency has released a report noting the ‘growing concern both among regulators and in public debate about how well these trials are conducted from an ethical and scientific/organisational standpoint…and the supervision of these trials.’ It noted that around 25% of patients used in ‘pivotal trials submitted between 2005 and 2008’ were recruited in Latin America, Asia, the former USSR and Africa.
As a result, over the next three years, EMEA is planning to widen its activities, notably to boost controls over pre-authorisation clinical trials carried out in these ‘non-traditional’ regions. This work will ‘encompass all areas of EMEA activity with impact on clinical trials, starting with the early activities such as scientific advice, orphan designation and paediatric investigation…through the finalisation of opinions on initial MAAs [market authorisation applications] and clinical trials conducted post-authorisation.’