title: [Clinical trials in oncology: deficits and proposals for solution].
abstract: Various investigations have identified deficits in clinical studies conducted for the market authorisation of haematological and oncological drugs. Based on data from European Public Assessment Reports (EPAR) of the European Medicines Agency (EMA), an analysis of the quality of these studies, which serve as the basis of marketing authorisation of currently approved drugs, is showing improvement. For example, endpoints recommended by the EMA are frequently used. However, deficits of marketing authorisation studies are still noticeable, e. g., results based on unplanned interim analyses or post hoc subgroup analyses. In addition to the improved quality of studies prior to marketing authorisation, independent clinical studies need to be conducted after marketing authorisation has been obtained, a good example of which are therapy optimisation studies (TOS) in acute lymphatic leukaemia (ALL). A goal of TOS is the examination of multimodal therapy concepts in the real world context of routine clinical practice. They can supply valuable data for drug safety and long-term observation. In order to conduct post-marketing authorisation studies, funding is required and bureaucratic hurdles associated with the 12(th) amendment to the Pharmaceutical Act will have to be reduced. The results of these studies are needed to efficiently handle limited health resources and to adequately inform and treat patients.
authors.affiliation: Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ). gisela.schott@akdae.de
authors.forename: Gisela
authors.initials: G
authors.lastname: Schott
authors.forename: Nicola
authors.initials: N
authors.lastname: Gökbuget
authors.forename: Henry
authors.initials: H
authors.lastname: Pachl
authors.forename: Wolf-Dieter
authors.initials: WD
authors.lastname: Ludwig
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015982:Bias; D015415:Biomarkers; D003131:Combined Modality Therapy / Q000592:standards; D057186:Comparative Effectiveness Research / Q000592:standards*; D017277:Drug Approval; D005858:Germany; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000628:therapy; D011785:Quality Assurance, Health Care / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D018570:Risk Assessment
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers