Research governance in placebo-controlled trials: Is the EMA/ICH position consistent in itself and in accordance with the declaration of helsinki?

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dc.identifier.uri http://dx.doi.org/10.15488/2346
dc.identifier.uri http://www.repo.uni-hannover.de/handle/123456789/2372
dc.contributor.author Lenk, Christian
dc.contributor.author Hoppe, Nils
dc.date.accessioned 2017-11-17T10:07:38Z
dc.date.available 2017-11-17T10:07:38Z
dc.date.issued 2014
dc.identifier.citation Lenk, C.; Hoppe, N.: Research governance in placebo-controlled trials: Is the EMA/ICH position consistent in itself and in accordance with the declaration of helsinki?. In: Medical Law International 14 (2014), Nr. 3, S. 115-132. DOI: https://doi.org/10.1177/0968533214547119
dc.description.abstract The European Medicines Agency and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use are powerful international institutions for the regulation of biomedical research. Although not directly concerned with the ethical aspects of research, both institutions have disseminated position papers on ethical issues relating to the use of placebos in clinical trials. What appears initially to be guidance on the methodology of placebo-controlled trials (with very technical content) clearly has some far-reaching implications for the extent of risk patients can be expected to be subjected to in such trials. On the basis of this guidance, this article questions how much additional harm to patients would be acceptable in placebo-controlled trials in comparison with active-control trials. The article will show that the instruments provided in the guidance are unsuitable, remaining unclear on vital points and thereby leaving patients, researchers and research ethics committees without appropriate direction. In conclusion, placebo-controlled trials urgently need more. © The Author(s) 2014. eng
dc.language.iso eng
dc.publisher London : SAGE Publications Ltd.
dc.relation.ispartofseries Medical Law International 14 (2014), Nr. 3
dc.rights Es gilt deutsches Urheberrecht. Das Dokument darf zum eigenen Gebrauch kostenfrei genutzt, aber nicht im Internet bereitgestellt oder an Außenstehende weitergegeben werden. Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
dc.subject placebo eng
dc.subject Conference Paper eng
dc.subject controlled clinical trial (topic) eng
dc.subject government regulation eng
dc.subject human eng
dc.subject methodology eng
dc.subject practice guideline eng
dc.subject research ethics eng
dc.subject study design eng
dc.subject.ddc 340 | Recht ger
dc.title Research governance in placebo-controlled trials: Is the EMA/ICH position consistent in itself and in accordance with the declaration of helsinki?
dc.type article
dc.type Text
dc.relation.issn 0968-5332
dc.relation.doi https://doi.org/10.1177/0968533214547119
dc.bibliographicCitation.issue 3
dc.bibliographicCitation.volume 14
dc.bibliographicCitation.firstPage 115
dc.bibliographicCitation.lastPage 132
dc.description.version publishedVersion
tib.accessRights frei zug�nglich


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