European regulators Struggle with Globalisation of Clinical Trials - Pharmaceutical Technology

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European regulators Struggle with Globalisation of Clinical Trials
The globalisation of clinical trials is putting pressure on the European Medicines Agency.


Pharmaceutical Technology Europe
Volume 24, Issue 6

The EMA under pressure

The EMA has received criticism from several MEPs for its perceived lack of action (9–11). In 2011, the EMA responded directly to the media, arguing that the globalisation of clinical trials was presenting it with a huge regulatory challenge that it was ill equipped to deal with. The EMA expressed the need for more resources and improved cooperation from the pharmaceutical industry to respond to the matters raised in the European Parliament, pointing out that all clinical trials, regardless of their nature, are required to meet internationally agreed ethical and data quality standards or their equivalent.

However, critics of the EMA are not satisfied. Wemos has argued that the regulatory agency is not being proactive and should be closely questioning companies about their conduct before granting regulatory approval for products (10, 11). In March 2012, MEPs on the Environment, Public Health and Food Safety Committee renewed demands for answers from the EMA regarding allegations of informed consent, inadequate investigation of deaths, conflicts of interest and other breaches for several trials conducted in India (11). The EMA acknowledged that there were still problems and promised to increase transparency to show how it was trying to enforce standards, but Dr Fergus Sweeney, the EMA's head of inspections, appeared to reject the demands of certain MEPs to refuse market authorisation for any ethical breaches (11).

Perhaps as a response to this criticism, the EMA has been keen to highlight the recent work it has been doing to ensure a robust global framework for the conduct and oversight of clinical trials. In April this year, the EMA's Working Group on Clinical Trials conducted outside of the EU and European Economic Area published a final reflection paper on the issue (13). The paper entered into force on 1 May 2012, with the aim of making sure that all standards are formally enforced, regardless of where in the world clinical trials are conducted.

One of the key steps that the EMA believes will enable it to enforce standards is better international cooperation. The agency recommended that a common international approach to the oversight of clinical trials be adopted, particularly with respect to countries where ethical and regulatory systems are not fully developed. A clear difficulty identified in the paper is for countries where EU regulators have limited existing formal contacts or experience in the local conduct of clinical trials (10).

As a starting point to prioritise its international focus, the EMA has collected data on the numerical distribution of patients participating in pivotal trials included in regulatory applications submitted to the Agency (10). In Africa, it identified South Africa as the major contributing country, whereas in Asia it was India, the Philippines, Thailand and China. In Latin America, a number of countries were highlighted including Brazil, Argentina, Mexico, Costa Rica and Peru. However, the EMA's data can only account for centrally authorised products, and so it is continuing to collect information at a Member State level and from international sources, such as the World Health Organisation (WHO) to create up a better picture of the situation.

From the available and emerging information, the EMA has proposed that high level "mapping" of information should be established in cooperation with individual European regulatory authorities and other international organisations (10). The exercise will effectively grade countries on the basis of the strengths and weaknesses of their regulatory systems, and whether the EMA can offer any assistance in the field of clinical trial regulation.

There will also be discussion on opportunities for collaboration based on the needs identified in the countries included in the priority list. The EMA already runs international collaborative projects in other areas, such as GMP inspections (14). The success of these programme can serve as a suitable framework to build collaboration for the purposes of enforcing clinical trial regulations.

The EMA has also noted that there are existing collaborative programmes in other regulatory areas, which may feature aspects of clinical trial regulation. Therefore, the agency is keen to look for synergies with other initiatives and to avoid the duplication of effort. However, the EMA has acknowledged that the results of some of the initiatives that have been conducted to date have not always been well documented, so there may be gaps in knowledge to overcome if its proposed international work is to complement existing programmes (13). There are also some basic, practical issues that the EMA must deal with such as developing a contact list of representatives of the foreign organisations it wants to deal with and determining appropriate communication measures.

For the EMA to become a stronger force for the enforcement of clinical trial regulations, it will also need greater resources and training. The final reflection paper mentions that training will involve courses, workshops and support for the preparation of guidelines and SOPs (10). However, it is not clear where the EMA will be getting additional resources from to cope with the growth of its activities or how they will be financed.


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