title: [Therapeutic trials in oncology. Legal aspects].
abstract: Therapeutic trials in the field of oncology regularly serve the dual purpose of expanding existing knowledge and meeting the doctor's obligation to provide medical care. Their objective is to check, modify or establish standards of treatment. In the form of clinical trials, they investigate the effects (efficacy, risks and other properties) of medicinal drugs. This applies both to new, as yet unapproved, drugs and also to drugs already in use, but now to be tested for an indication other than that for which they were originally approved. This applies to trials sponsored by the pharmaceutical industry and to studies not so sponsored. These clinical trials are subject to the regulations of pharmaceutical law (AMG), while others are assessed in accordance with the exemplary principles expressed in sec. 40 AMG. All therapeutic studies are required by pharmaceutical law or professional law to be reviewed by ethics committees (approval/advising). All such studies must comply with strict legitimation requirements of liability law. They may be carried out only when there has been a positive benefit/-risk assessment that promises results that are at least equal to those obtainable with standard treatment. Patient information requirements are strict and include the provision of information about alternative forms of treatment as well as about the absence of health insurance funding-where this applies- and the future funding of further treatment on termination of the study. Documentation obligations are extensive, and organizational requirements include the establishment of quality management. In the case of clinical trials, the conclusion of an insurance contract for the participants is mandatory, and in the case of other therapeutic studies urgently recommended. Therapeutic studies may be funded by statutory health insurance carriers within the framework of study regulations or quality assurance measures. This does not apply to clinical trials of drugs on behalf of the pharmaceutical industry.
authors.affiliation: Fachbereich Rechtswissenschaft, Universität Bremen.
authors.forename: D
authors.initials: D
authors.lastname: Hart
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004992:Ethics, Medical; D005500:Follow-Up Studies; D006801:Humans; D007348:Insurance, Health / Q000331:legislation & jurisprudence; D009369:Neoplasms / Q000188:drug therapy*; D011379:Prognosis; D011786:Quality Control
vernacular_title: Therapiestudien in der Onkologie. Rechtliche Aspekte.