How can we improve paediatric clinical trials in Europe to meet the participation and outcome needs of the children involved and their families? This book is the result of a three-year EU Seventh Framework coordination project identifying children’s needs in the clinical trials context. It is based on Europe-wide discussions of the issues facing paediatric clinical trials in Europe today and a comprehensive review of the literature; in addition, interviews, surveys and workshops were carried out across Europe with children participating in clinical trials, their parents, their support organisations, representatives of ethics committees and professionals planning and carrying out paediatric clinical trials. The project and this book answer three questions:
By incorporating the child’s participation and outcome needs into the planning process of a clinical trial, a partnership model of empowerment emerges, based on four elements:
Demonstration projects and examples of best practice are presented, illustrating how these elements of empowerment can be applied in real world contexts.This book will be invaluable to researchers, clinicians, sponsors, patient organisations, parents and children themselves. It presents specific recommendations and action points for all those involved in clinical trials. Priority must be given to the empowerment of children as a way forward to improving paediatric clinical trial practice in Europe.
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