Ethics of off-label treatment.

Atkins, Carl D.

doi:10.1200/jco.1998.16.4.1637

Cited by 2 publications

(2 citation statements)

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“…1 Am häufigsten (133 Zentren) wird es subkutan verwendet, am zweithäufigsten inhalativ von 64 Zentren (39 urologische und 25 internistisch-onkologische Abteilungen), 24 Zentren (9 urologische und 16 internistisch-onkologische Abteilungen) setzen weitere lokale Verfahren ein. Die Zahlen bestäti-gen das Schlusswort von Fischer im Deutschen Ärzteblatt im Frühjahr dieses Jahres [7]:…”

Section: Applikationsformenunclassified

“…Die American Medical Association informiert, dass 40-60% aller Verordnungen in den USA "off label" sind -Zahlen, die auf Deutschland vergleichbar zutreffen. Die FDA hält die "Off-Label-Behandlung" für rational und angemessen ("... the legitimate use of chemotherapy is determined by the totality of medical evidence, not by FDAlabeling; [1,6]). …”

Section: Off-label-behandlungunclassified

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Immuntherapie des metastasierten Nierenzellkarzinoms in Deutschland Eine Standortbestimmung

Huland¹,

Heinzer²,

Timm³

et al. 2002

Urologe [A]

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Section: Applikationsformenunclassified

Section: Off-label-behandlungunclassified

Immuntherapie des metastasierten Nierenzellkarzinoms in Deutschland Eine Standortbestimmung

Huland¹,

Heinzer²,

Timm³

et al. 2002

Urologe [A]

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Off-label therapies in oncology

Telekes

2009

Orvosi Hetilap

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The unapproved (off-label) therapies represent a special problem in oncology since they are in the borderline of legal regulation and of free medical practice. Although in Hungary the off-label therapies were regarded as clinical trials without permission until the new regulation came into action at the end of October 2008, certain experts were even so arguing for its use because clinical practice changes more rapidly than the prescription label. Moreover, manufacturers are not obliged to submit Supplemental New Drug Application in spite of the fact that enough evidence is generated to do so. The regulation of off-label therapies should meet the conditions of free medical practice, evidence-based medicine, demand of patients for new chances and expectations of regulatory authorities. In this paper, following the criticism of the Hungarian status and the new regulation, as well as the review of international practice, the author outlines the frame of a potential regulation separately indicating the role of practicing physicians and authorities.

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Ethics of off-label treatment.

Cited by 2 publications

References 0 publications

Immuntherapie des metastasierten Nierenzellkarzinoms in Deutschland Eine Standortbestimmung

Immuntherapie des metastasierten Nierenzellkarzinoms in Deutschland Eine Standortbestimmung

Off-label therapies in oncology

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