From exclusion to inclusion : improving clinical research in vulnerable populations ; memorandum

Therapeutic care for vulnerable populations – meaning patient groups such as underage children and the mentally ill that have limited or no capacity for giving informed consent – is severely lacking. Thus, for example, a great portion of pharmaceuticals used in the treatment of children and youth have not been specifically designed for these groups, which often results in side effects that are disproportionate to those associated with such medicines when used by adults. Moreover, vulnerable populations are at times faced with having no therapies at all for some of their ailments, such that children and dementia sufferers, for example, are often considered to be “therapeutic orphans”. It is therefore urgent that clinical research be carried out among vulnerable populations in order to improve their therapeutic possibilities. The Clinical Research on Vulnerable Populations Research Group – a cooperative effort between the Berlin-Brandenburg Academy of Sciences and Humanities (Berlin, Germany) and the European Academy of Technology Assessment (Bad Neuenahr, Germany) – has set itself the task of analyzing the state of clinical research on vulnerable populations so as to be able to develop suggestions for improving future research of this kind. The results of this work are presented in the following memorandum, which seeks to portray the state-of-the-art in this domain while also assessing the strengths and weaknesses of contemporary ethical and medical perspectives related to it. The memorandum is primarily oriented towards those in the relevant scientific disciplines who can benefit from obtaining an informed consensus regarding the current state of the discussions taking place around this topic.