Ethical Challenges in Clinical Research at Both Ends of Life
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Peter Wrobel Clarit-v in Science Communication. UK
Martine Dehlinger-Kremer Lead. Paediatric Workin# Group E U C R O F ; Vice President. Global RA Omnicare Clinical Research
Ingrid Klingrnann Chairman. EFGCP; and CEO Pliarmaplex. Belgium
Key Words Clinical research: Ethics: Pediatrics; Geriatrics
Correspondence Address Peter Wrobel.
I 1 Fulready Road. London E I 0 6DT (email: c h i t - v @wrobel.net).
Report o j t h e EFGCPE L C R O F joint workshop on common lessons t o be Ieurned jrom pediatric and geriatric clinical development held at the Crowne Plaza. Antwerp. Belgium. April 27 and
28.2010.
This article summarizes the conclusions and discussion from a workshop in Brussels, jointly organized by the European Forum for Good Clinical Practice and the European CRO Federation, looking at how pediatric and geriatric clinical research might learn from each other in dealing with the ethical issues particular to each area. Experience with the Paediatric Regulation, which since 2007 has provided the legal framework in Europe for all research involving children, suggests that the incorporation of geriatric expertise at all lev-
INTRODUCTION AND WORKSHOP STRUCTURE Childhood and old age-Shakespeare’s “second childhood”-are both very different and very similar. Neither stage in life is capable of being defined simply: neither is physiologically uniform: both populations can be considered as vulnerable: and both raise complex problems of treatment, especially (but not solely) ethical issues. Working at different ends of the spectrum of life, professionals involved in pediatric and geriatric research rarely get to talk to each other. But at a conference on aging organized by the European Forum for Good Clinical Practice (EFGCP) in 2009, the idea came up that researchers in the field could learn much from pediatrics, and vice versa. In particular, there was debate about the opinion that experiences in applying the Paediatric Regulation might spur the realization of similar legislation-currently completely absent-to kick-start research activity in the field of geriatrics. Hence this unique workshop, organized by the EFGCP and the European Contract Research organization Federation (EUCR0F)-a coming together of more than 50 specialists
els in the drug discovery process, including ethics committees, would yield considerable benefits. This should be combined with an upward revision of the age ranges that define who is elderly and a public debate about the need for research involving elderly people. Further work on practical guidelines on the ethical conduct of clinical trials in elderly people should be a priority. In both pediatric and geriatric research, the concepts of consent, assent, and dissent require further elaboration.
from across Europe working in various aspects of both worlds, which took place over two days in Antwerp, Belgium. The workshop began with a scene setting of the principal unsolved issues in pediatric and geriatric research. It was followed the next morning by two sessions on the ethical challenges
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