Nutzen aus klinischer forschung: Auch für patienten und probanden?

Translated title of the contribution: When and how do patients benefit from clinical research?

Heiner Raspe*

*Corresponding author for this work


The Convention on Human Rights and Biomedicine, its Additional Protocol, the European Parliament’s Good Clinical Practice (GCP)-Directive as well as the German Medicines Law and GCP-Decree all require certain forms of „benefit” for participants of clinical trials and other forms of clinical-evaluative research. However, they do not provide any attempt to define e. g. „direct benefit” or group benefit - contrary to our text. It additionally discusses qualitative and quantitative aspects and the inherently probabilistic nature of any benefit from clinical research. Clinically most relevant study types and designs (such as placebo-controlled trials; diagnostic studies of phases 1 - 3) do not offer any potential individual benefit at least for parts of the samples, they are at best beneficial for the group of similarly affected patients. At present those trials if including incapacitated adults not able to give informed consent are forbidden by German law, a situation different from that of trials involving minors.
Translated title of the contributionWhen and how do patients benefit from clinical research?
Original languageGerman
JournalDeutsche Medizinische Wochenschrift
Issue number28-29
Pages (from-to)1701-1705
Number of pages5
Publication statusPublished - 15.07.2005


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