Duration: 36 months (June 2008 – August 2011) | Status: completed non EPF-led project |Funding Programme: Seventh Framework Programme for Research and Technological Development (FP7)
What is the project about?
RESPECT = Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials
RESPECT has provided an important contribution to improving the way paediatric trials are designed and run. The aim was to identify the needs and motivations of children and their families who have participated or might participate in clinical trials in Europe in order to further identify methods by which these needs can be translated into empowering and motivating participants.
This project grew from the observation that over 50 percent of medicinal products used to treat children may not have been tested or authorised for their use. This left health care professionals with no alternative but to use medicines "off-label". They had to judge the suitability and the correct dose of these medicines themselves in the absence of paediatric labelling information. This posed significant risks of inefficacy and/or adverse reactions for children.
The major impact of this project has been on the promotion of clinical trials for the development of innovative medicines to improve child health and treat paediatric diseases. Increased cooperation between different partners in the clinical trials landscape will help to make clinical trials more effective and thus encourage greater innovation and industry development.
RESPECT advanced our understanding of how to more efficiently promote good clinical practice in paediatric clinical trials research through a debate between different actors within this field and identification and sharing of best practices.
The project was led by the Institute of Clinical Sciences at the Sahlgrenska Academy at Gothenburg University, Sweden. The following organisations were partners in the project:
- University of Gothenburg, Paediatric Growth Centre
- University Hospital of Hamburg-Eppendorf, Department of Medical Psychology
- European Patients Forum
- University Children's Hospital Ljubljana and the Foundation of Child Neurology
- Good Clinical Practice Alliance Europe
- Azienda Ospedaliera di Padova
- Consorzio valutazione Biologiche e Farmacologiche (Pavia)
Impact on the patient community
Understanding the needs of children and families participating to clinical studies can contribute to an increased participation in these studies, thus resulting into the delivery of drugs and treatments better tailored at children’s needs than currently.
Page last modified: 28 August 2012