Strategies for pediatric trials - Ethical aspects of drug research in view of the research-based pharmaceutical industry

Drug development and information (labeling) for children are considered as insufficient. A lack of incentives and the special challenges in pediatric research are mentioned as hurdles to establish pediatric studies and generate the appropriate knowledge for the use of medicinal products in the pediatric population. The research-based pharmaceutical manufacturer association (VfA) has developed a position paper with a variety of proposals to improve the situation for children and beyond the issues to discuss the opportunities of pediatric research. In particular, ethical considerations for the protection of children based upon the EU-Directive as well as scientific, regulatory and administrative perspectives for the realization of projects and incentives following the initiatives of the Food and Drug Administration Modernization Act (FDAMA) are needed in order to involve children in the therapeutic developments of innovative drug research.