RESPECT

Relating Expectations and needs to Participation and Empowerment of children in Clinical Trials

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 Obiettivo del progetto (Objective)

'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.'

Introduzione (Teaser)

A group of EU-funded researchers responded to the EU's Seventh Framework Programme call for a coordination study identifying patients' needs in the context of clinical trials.

Descrizione progetto (Article)

The http://www.patientneeds.eu/ ('Relating expectations and needs to participation and empowerment of children in clinical trials') (RESPECT) project examined opportunities for improving recruitment to clinical trials by empowering children and their parents. Prompted by the 2007 European paediatric regulation, team members investigated the reasons for participation and explored a model of empowerment.

In order to gain extended health-care benefits and cost savings, the RESPECT consortium identified the needs of children and their families as these relate to clinical trials of new drugs in Europe. They also examined methods for translating these needs into empowering and motivating participants in future clinical trials' research.

These aims were realised though work covering three objectives. The first was to construct a common basis for understanding, and the second was to collect and analyse various approaches and practices for recruiting patients into clinical trials in different medical areas and conditions. The third was to disseminate project findings to open up the debate and encourage the adoption of better empowerment and recruitment methodologies.

Project partners utilised a range of methodologies to analyse current European patient perspectives on clinical trials, selecting and adapting them according to the specific groups studied and the project's needs. Case study interviews and surveys were used for child participants and potential participants in clinical trials. The main emphasis was on obtaining qualitatively rich data that included the families' stories of why they agreed to participate and why they continued to participate.

RESPECT research has improved our understanding of patient needs, attitudes, expectations, motivations and perceived barriers to participation in clinical trials. Among the findings of the coordinated action was that parent- and child-friendly clinical trials will likely increase participation and transparency. Patient organisations are key to effecting change in this respect. Another finding was that immigrants are frequently excluded from clinical trials, based on the assumption that they will not understand the instructions because of low educational levels. This points to a need to be more inclusive and provide cultural mediation, not just translation.

RESPECT project efforts and activities have produced high-quality research, identifying the needs and motivations of children and their families taking part in clinical trials. Enhanced networking and a stronger and more fruitful coordination of different actors having an equal role has been realised. This will benefit both research and patients. Project results can be applied to all medications and all medical conditions, and are also transferable to adult clinical trials.