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Clinical research in Germany with special focus on non-commercial studies. Summary

Bührlen, Bernhard; Georgieff, Peter; Vollmar, Horst Christian


Clinical research is of paramount importance both for the development of new medicinal products and other medical treatment procedures and for ensuring and optimising the application of the procedures in routine practice. All resulting clinical studies are regulated by the German Medicines Act (AMG), provided they investigate the efficacy, safety or metabolism of medicinal products with the aim of testing their safety or efficacy. This type of clinical study is referred to as a "clinical trial".
Insofar as clinical research is associated with commercial interests - such as the goal of obtaining marketing authorisation for a new active substance - it is initiated and financed by the developer or manufacturer of the preparation or procedure. However, if the commercial expectations associated with the study results are low or non-existent, especially if the product already has market approval, a private-sector sponsor is often not found. Clinical trials without private funding but which are of public interest are referred to as non-commercial clinical research, science-initiated clinical trials or investigator-initiated trials (IIT), sometimes also as therapy optimisation studies. ... mehr

Volltext §
DOI: 10.5445/IR/1000137883
Veröffentlicht am 22.10.2021
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Technikfolgenabschätzung und Systemanalyse (ITAS)
Publikationstyp Forschungsbericht/Preprint
Publikationsmonat/-jahr 01.2010
Sprache Englisch
Identifikator ISSN: 2364-2599
KITopen-ID: 1000137883
Verlag Büro für Technikfolgen-Abschätzung beim Deutschen Bundestag (TAB)
Umfang 4 S.
Serie TAB Working report ; 135
Externe Relationen Siehe auch
Schlagwörter Medical research; technology assessment; research policy
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