| Benefits from clinical research: for both patients and test subjects? | |
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MedLine Citation:
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PMID: 16003607 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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H Raspe |
Publication Detail:
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Type: English Abstract; Journal Article; Review |
Journal Detail:
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Title: Deutsche medizinische Wochenschrift (1946) Volume: 130 ISSN: 0012-0472 ISO Abbreviation: Dtsch. Med. Wochenschr. Publication Date: 2005 Jul |
Date Detail:
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Created Date: 2005-07-08 Completed Date: 2005-08-04 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0006723 Medline TA: Dtsch Med Wochenschr Country: Germany |
Other Details:
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Languages: ger Pagination: 1701-5 Citation Subset: IM |
Affiliation:
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Institut für Sozialmedizin, Universitätsklinikum Schleswig-Holstein, Campus Lübeck. heiner.raspe@sozmed.uni-luebeck.de |
Vernacular Title:
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Nutzen aus klinischer Forschung: auch für Patienten und Probanden? |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biomedical Research
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classification,
ethics,
standards* Humans Placebos / standards Prognosis Research Subjects* Risk Assessment |
| Chemical | |
Reg. No./Substance:
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0/Placebos |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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