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Biomedical innovations and clinical research. Summary

Bührlen, Bernhard; Vollmar, Horst Christian


Clinical research is an important part of the development of new medicines, medical devices and other therapeutic methods, such as surgical procedures. It includes various types of human studies that - with different focuses - test the efficacy and safety of new products and procedures. The data obtained are used on the one hand for applications for market approval of new procedures, but on the other hand also to improve health care practice by answering questions from clinical practice and using already introduced procedures in a more targeted and efficient way. In particular, the large patient studies that are required for the marketing authorisation of medicinal products are associated with a great deal of effort and considerable costs. On the other hand, they also mean a not inconsiderable factor for the labour market for researchers and study personnel. Despite internationally recognised guidelines that are largely cast in law, there are significant differences in their implementation at the national level. The existing leeway opens up the possibility for countries to optimise the conditions for clinical research at the location, but there is also the danger that clinical research could migrate to countries with more favourable conditions.
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Volltext §
DOI: 10.5445/IR/1000137952
Veröffentlicht am 22.10.2021
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Technikfolgenabschätzung und Systemanalyse (ITAS)
Publikationstyp Forschungsbericht/Preprint
Publikationsmonat/-jahr 06.2009
Sprache Englisch
Identifikator ISSN: 2364-2599
KITopen-ID: 1000137952
Verlag Büro für Technikfolgen-Abschätzung beim Deutschen Bundestag (TAB)
Umfang 7 S.
Serie TAB Working report ; 132
Externe Relationen Siehe auch
Schlagwörter Biomedicine; Technology Assessment; Drug research; Innovation; Medical research; Regulation; Competition
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