Medical research and drug development are focused typically on an adult population of patients frequently

excluding, at one end of the age spectrum, children and, at the other, the elderly and frail. Reasons for these

exclusions are multiple and are not the same for both populations, but typical hurdles are shared as e.g. ethical

concerns about informed consent, the need for specific formulations, specific adaptations of protocol procedures

etc.

Therefore these vulnerable populations are today unrepresented in research and drug development. Once a drug

is on the market and used, clinicians, patients and caregivers have to base their treatment decisions on empiric

data and dose assumptions and not on scientific valid data.

This lack of data was already identified in the past, but specifically only for children. Thus drug development

regulatory bodies, academia, researchers and patients’ advocacy groups have recently agreed on improved and

clear guidelines for research involving children. Much to be welcomed is the recently implemented, and in force in

Europe since 2008, Paediatric Investigation Plan (PIP) for all new drugs in development.

At the other end of life, for the older and frail people, a lot of effort has still to be done as existing international

recommendations and regulations are under review and the next steps to define what they will yield and how they

will improve the situation are under discussion.

The European Forum for Good Clinical Practice (EFGCP) and The European CRO Federation (EUCROF) have

thus brought together experts from both fields, experts in clinical research, ethics, social, patient organisations and

pharmaceutical regulatory bodies to explore the shared ethical issues and to learn lessons from each other.

The objective of this workshop is to share concerns, to detect possible synergies and to learn from each other in

order to improve and to facilitate and promulgate high quality ethical clinical research and drug development for

these important populations across the whole of the European Union.