Empowering child participation in clinical trials
The '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.