• Technology

• Health

• Environment

• Project Co-ordinator: Dr. phil. Margret Engelhard, Dipl.-Biol.

• Documentation: Graue Reihe 46: „Clinical research in minors and the mentally ill”, 11/2008

• Duration: 12/08–6/11 

• Funding: Berlin-Brandenburgische Akademie der Wissenschaften (partly)

• Further Information on “Pharmaceuticals”

   

The therapeutic situation of vulnerable populations – such as minors, elderly, and the mentally ill – is unsatisfactory. For example, a large part of pharmaceuticals which is given to minors is used “off label” or “off licence”, resulting in disproportionately numerous adverse side effects. What seems even worse, for many conditions there is no validated therapy available leaving for example demented patients behind as “therapeutic orphans”. It is, therefore, an urgent task to foster clinical research in vulnerable populations and to discuss the medical ethical, legal and economic problems involved. To begin with, it is debated, to what extent and on which ethical and legal foundation risky research on vulnerable populations is acceptable at all. In addition, the realisation of clinical studies in smaller groups of patients (i.e. infants, minors, adolescents) is complex, time-consuming, and therefore very costly. Thus, the question arises whether effective incentives to perform research are in place and whether the established ways of drug development are appropriate for fulfilling societal needs. Also a main concern of researchers both from universities and industry remains to find sufficient numbers of vulnerable populations as test persons. Here the discussion on appropriate incentives arises once again. Finally, the obvious globalisation of clinical research raises concerns often expressed in the fear that due to a “research colonialism” benefits and risks of research might be unjustly distributed between the western and the developing world.
The project aims at developing recommendations for the improvement of clinical research and consequently an improvement of the therapeutic situation of vulnerable populations.
The project is a collaboration between the Europäische Akademie and the Berlin-Brandenburgische Akademie der Wissenschaften (BBAW).

Pharmaceuticals