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Background information on clinical trial regulation advocacy

Related to GA Agenda item 9.4

 

Background

The European Commission has recognised the criticisms made of the existing regulatory regime for clinical trial regulation in Europe and accordingly was developing its proposals for reform throughout 2011 and 2012.

In advance of its publication the 2012 EAHP General Assembly passed a statement on clinical trial regulation, setting out hospital pharmacist views on areas requiring attention. This focused on the need for greater transparency about how clinical trial results are published, efforts to be made to improve under-represented patient group participation (e.g. older people, children, females), and gave general support for suggestions of risk-adapted approaches to regulation (e.g. lower burden requirements for low intervention trials). More information here.

 

Activity since last General Assembly

Following the passage of the new EAHP statement, the Commission published their proposals for reform of the Clinical Trials Directive in July 2012 (information here) and EAHP met with the Commission to discuss our views shortly thereafter (information here).

Beyond this, EAHP has been working with organisations with a common interest to present joint amendments and messages to the European Parliament. This includes partners in the European Public Health Alliance (EPHA) such as: Cancer Research UK, the European AIDS Treatment Group (EATG), the European Heart Network, AGE Platform Europe, and the European Hematology Association (EHA). 

In November 2012 EAHP took part in a joint briefing supporting many aspects of the Commission's proposals but seeking greater clarity about how certain aspects (e.g. risk-proportionate measures) would operate in practice. Joint briefing here.

EAHP also helped to develop, and supported, an EPHA position paper on clinical trials, which reemphasised the need for efforts to improve patient group participation. Paper here.

Following this activity, at the end of January 2013 Glenis Wilmott MEP (UK, Socialist Group) published her draft report on behalf of the European Parliament's ENVI (health) Committee. The draft report is available in different languages here. Opinion reports were also published around the same time by the Civil Liberties Committee, the Industry and Research Committee, and the Internal Market Committee (IMCO).

Amendments of the Parliament have focused on the extent of trial result transparency measures (in particular as to whether all trial results should be reported in the form of clinical study reports) and the handling of personal data (e.g. for how long this should be held and when or if it should be destroyed).

In the meantime, a campaign called AllTrials, led by the Cochrane Collaboration, British Medical Journal and Sense about Science, has been leading an collaborative advocacy exercise to ensure all trials are fully reported, not just successful trials. The April Board Meeting of EAHP agreed to join the organisations supporting the campaign. See supporting organisations here.

Separately to the above, EAHP has attended many meetings of the European Medicines Agency to give health professional input to the development of their clinical trials database (EUDRACT) and nominated representatives to its 5 working groups investigating trial data access issues. More information here.

 

Next steps

The European Parliament's ENVI Committee is scheduled to vote on the content of its final report on the Commission proposals on clinical trial regulation at the end of May 2013. After this vote the subject file will enter a process of "trilogue" discussion between the European Parliament, the European Commission and Council of Ministers (representing national Governments). The subject file is due to be closed by a final vote of the whole European Parliament in October 2013.

EAHP will continue to work with partner organisations (e.g. through EPHA, Alltrials and others) in scrutinising and giving advice and suggestions to Parliament, the Commission and Governments in relation to proposed amendments to regulation.

Otherwise, the reforms to the Directive should represent improvements to the current regulatory regime, with greater public and professional access to clinical trial data, separation of regulatory burden for high and low intervention trials, and the possibility of co-sponsorship of trials.

Activity throughout 2012 has also helped to raise the profile of hospital pharmacists in relation to clinical trial activity with relevant European audiences, and assisted in building alliances with stakeholder organisations with similar interests. For example, Members of the European Parliament proactively saught the opinion of EAHP on proposed and potential amendments.

EAHP will continue to input to European Medicines Agency activity in relation to clinical trials, in particular the operation and accessibility of the EUDRACT database.

*EAHP would like to thank Velina Dimitrova, Hana Bakhouche, Sebastião Ferreira da Silva, and Carla Sousa, for their help and assistance in representing the hospital pharmacist perspective to the EMA trial data working groups. 

 

 

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