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The European Association of Hospital Pharmacists (EAHP) has given an early welcome to the recently published proposals of the European Commission to improve the regulation of clinical trials (published 17 July 2012).
The Commission's proposals have met the aspirations of a recent EAHP statement on trial regulation in four key areas:
The introduction of new risk-based approaches to clinical trial regulation with the concept of low-interventional clinical trials for products with existing marketing authorisation and which are considered standard treatment in the member state.
New provisions to allow co-sponsorship of trials.
Centralised application procedures to enable multinational trial applications to be submitted to a single electronic portal for delegated single assessment.
The maintenance of ethics committees and procedures at a national level.
EAHP will now scrutinise the proposals in more detail before meeting with the Commission in September. EAHP want to explore what more can be done to open up access to clinical trial data, and how participation in trials by key patient groups, such as older people, can be increased.
Commenting on the Commission's proposals, EAHP President Dr Roberto Frontini said:
I am pleased that the Commission have taken on board the comments and concerns expressed by stakeholders, including hospital pharmacists, in relation to clinical trial regulation in Europe. These proposals are certainly a step in the right direction, addressing many of the key problems of regulatory burden.
However, one area where we undoubtedly want to see more action on is the access to clinical trial data available to health professionals such as hospital pharmacists. This is critical for many reasons, including independent review and ethical decision-making. We are certain that there is more that can be achieved and we will develop our suggestions further as we scrutinise in detail the Commission proposals in the coming months.
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Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.