[Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].
Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.
Benninger-Döring
G
G
Koordinierungszentrum für Klinische Studien, Universitätsklinikum Münster, 48129 Münster. gbd@uni-muenster.de
Boos
J
J
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003132:Commerce; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D017410:Practice Guidelines as Topic