EUCROF-EFGCP Joint Workshop, 27-28 April 2010,
THE EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE
and
THE EUROPEAN CRO FEDERATION
announce
EFGCP-EUCROF Joint Workshop on
Ethical Challenges in Clinical Research at
Both Ends of Life
Common Lessons to be learnt
from Paediatric & Geriatric Clinical Development
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
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 organizations 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.
For further information about the agenda (Workshop-Program) and registration:
On February 26, 2009, the Japanese CRO Association – JCROA – celebrated their 15th anniversary with a Commemorative Symposium titled
“The new paradigm/stream in the clinical development – how to adopt
The symposium program can be found here.
Guest speakers were invited from the
Before the symposium, the heads of the three CRO organisations (Kazuo Nakamura for JCROA, Derek Winstanly for ACRO and Antoine Cournot for EUCROF) signed the TOKYO DECLARATION, a commitment to patient safety, data integrity and scientific quality as well as fair competition in the CRO industry. The assembly of JCROA, ACRO and EUCROF in
