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Clinical Trials

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Clinical research brings new treatments to patients. New treatments can be new drugs developed by the pharmaceutical and biotechnology industries, new cell therapies and other forms of advanced therapies, new surgical procedures or new approaches to managing a patient suffering from a chronic medical condition, as well as others.

Clinical research also encompasses epidemiological research aiming at measuring the health of citizens and determining the health-related conditions under which people live.

In public health research, clinical research aims at determining the effectiveness of treatment approaches at population level or the efficiency and effectiveness of the organisation of health services.

Clinical trials for the development of a new drug are, for the most part, initiated and financed by industry. There are also many clinical trials initiated by academic clinical researchers. Whether initiated by industry or by academic clinical investigators, clinical research is often performed in national, European and worldwide consortia, which can sometimes be very large ones.

Clinical research raises profound ethical and safety questions. The protection of participants in a clinical trial is of paramount importance. As a consequence, clinical research is highly regulated. To facilitate collaborations across borders, many aspects of this regulation are harmonised at the European level but also worldwide.

Some of the administrative aspects of the regulation of clinical research are considered burdensome, without contributing to the safety of trial participants. Especially the academic clinical trials community has raised concerns that performing clinical research has become too complicated and costly.

Clinical research is a main focus for funding research through the health theme of the cooperation programme of FP7. Therefore a number of topics in the annual work programmes address clinical research. In most cases financial contribution from the European Commission (EC) will be limited to Phase I and Phase II clinical trials. Recently, work programmes have had topics on the development of drugs for special populations, e.g. in rare diseases or for the development of off-patent medicines for children. In such cases EC contribution can also be provided for Phase III trials.

All proposals for funding involving a research intervention on humans, the use of human embryonic stem cells and/or foetal tissues, or non-human primates are automatically submitted to an ethical review.

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