There are two objectives for this project, firstly to clarify the expectations and needs of children and their families who have participated or who might participate in clinical trials for new drugs in Europe. Secondly, to identify methods by which the expectations and needs can be translated into empowering and motivating participants in future clinical trails research. This will be achieved in three stages. The partners will be from different areas involving patients, clinicians, regulators, and researchers (industrial and academic) on a broad basis in order to cover a broad spectrum of diseases. Stage 1) The project will construct a basis for coordination and harmonization. This will involve a literature search and a preliminary workshop. We will build a web site for communication within the project and with a wider audience. Stage 2) We will ground our diverse experience and knowledge through benchmarking good practice case studies, and collecting opinions from patients’ organisations in Europe. The results will be presented at an expert harmonization workshop composed of all partners of the project. This workshop will identify the operating procedures needed to encourage empowerment and increase motivation for participation in clinical trials. Stage 3) The results of the project will be presented in a series of European conferences. This will ensure that the impact on clinical practice will be facilitated. This will help to improve translational research which depends upon the clinical trial process being undertaken with large enough populations to ensure safety of new products. Greater participation in clinical trials research will result in more valid and reliable products available for children as envisaged by the EC 1901/2006 Paediatric Regulation. In addition it will make European health businesses more competitive and will improve the global health in Europe.
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