Outcomes of the clinical trials meeting
The activities of the meeting on clinical trials organised by the EMEA on 3 October 2007 focused on strengths and shortcomings of the current legal framework. No general consensus was risen in this matter. In particular, the debate was characterised by diverging opinions on the directive’s quality.
A call for simplification and a risk based approach were addressed.
Non-commercial stakeholders highlighted the importance of having non-commercial or independent clinical trials to compensate and complement commercial ones since they focus on different medicines and diseases.
A member of the patients’ and consumers’ working party (PCWP) stressed the importance of: 1) including the PCWP in the clinical trial facilitating group (CTFG), 2) a harmonised approach for ’informed consent’, 3) an European leadership in R&D focused on quality.
EMEA’s information to stakeholders
The EMEA is developing an "EMEA vision on provision of information to the Agency’s stakeholders" as part of the implementation of the EMEA Road Map to 2010. In this regard, many aspects were addressed in the brainstorming meeting held on Thursday 20 September 2007 at the EMEA premises in London (a draft agenda of the meeting is available below). Moreover, on 21 September 2008 the patients’ and consumers’ working party (PCWP) was summoned to discuss on the Work Plan.
During the debate, a number of interesting points have been highlighted:
it was generally agreed that EMEA website needs to be simplified to facilitate users’ access,
the Pharmaceutical Group of the European Union (PGEU) suggested to use terminology of medicines instead of products,
the Health Action international drew attention to: 1) the fact that a number of countries do not have on-line access to the statutory information, 2) the limited access to main documents concerning the European public assessment reports (EPARs).
The aforementioned points were taken into account by EMEA representatives who ensured:
the website’s improvement in terms of access to databases such as EudraVigilance and Eurodata,
a different presentation and availability of EPARs.
The scope of the meeting was to provide an opportunity for the Agency’s stakeholders to express their needs and expectations in relation to the provision of information by the EMEA and the use of available information tools. Here, consumers’ and patients’ organisations agreed that patients should be better informed on the outcomes of clinical trials.
EMEA improves its website section for patient and consumers
The section of the European Medicines Agency (EMEA) website dedicated to patients and consumers was greatly updated during 2007 to improve access to EMEA information that is of greatest interest to them.
The “Working with patients and consumers” section of the EMEA website provides a practical overview of the various types of information about medicines that the EMEA publishes, with convenient links to further information.
This section, developed together with the Patients and Consumers Working Party, also addresses the opportunities created for patients’ and consumers’ organizations to participate in the agency’s activities.
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