title: [Do we still need clinical studies in rheumatology?].
abstract: Despite a large number of approved therapies demonstrating efficacy in the treatment of rheumatic diseases, only 60-85 % of patients with the indications for rheumatoid arthritis are adequately treated in Germany. Additionally, approved therapies for other immune-mediated diseases are often entirely lacking, indicating the great medical need for the development of new innovative therapies in this specialized field. The development of new drugs is expensive due to the high costs of conducting clinical trials in all phases of development up to obtaining approval; therefore, pharmaceutical companies are looking for ways to save costs in the particular developmental stages. Although the classical regions for drug development (i.e. western Europe, the USA and Japan) offer both a high level of data quality and a good infrastructure to conduct clinical trials due to high standards of education and quality, clinical trials are expensive in these regions. Beside high costs, the comparatively low recruitment rates in these regions are one of the main reasons for the shifting of drug developmental stages from classical regions to eastern European, Latin American and Asian countries, which provide services for drug development and high recruitment rates for comparatively less money. However, there are many strong arguments for the participation of regions in western Europe, especially German sites in clinical trials. In this article these arguments are discussed and possible solutions and strategies for conducting and compensation of study centers in Germany for clinical trials in the field of rheumatology are provided.
authors.affiliation: Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie, Sandhöfer Allee 6, 60528, Frankfurt am Main, Deutschland. henkemeier@ciri-clinical.de.
authors.forename: U
authors.initials: U
authors.lastname: Henkemeier
authors.affiliation: Schlosspark-Klinik, Berlin, Deutschland.
authors.forename: R
authors.initials: R
authors.lastname: Alten
authors.affiliation: Medizinische Universitätsklinik Freiburg, Freiburg, Deutschland.
authors.forename: B
authors.initials: B
authors.lastname: Bannert
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Deutschland.
authors.forename: X
authors.initials: X
authors.lastname: Baraliakos
authors.affiliation: Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie, Sandhöfer Allee 6, 60528, Frankfurt am Main, Deutschland.
authors.forename: F
authors.initials: F
authors.lastname: Behrens
authors.affiliation: Zeisigwaldkliniken Bethanien, Chemnitz, Deutschland.
authors.forename: F
authors.initials: F
authors.lastname: Heldmann
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Deutschland.
authors.forename: U
authors.initials: U
authors.lastname: Kiltz
authors.affiliation: Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie, Sandhöfer Allee 6, 60528, Frankfurt am Main, Deutschland.
authors.forename: M
authors.initials: M
authors.lastname: Köhm
authors.affiliation: Kerckhoff-Klinik, Bad Nauheim, Deutschland.
authors.forename: R
authors.initials: R
authors.lastname: König
authors.affiliation: Klinikum der Universität München, München, Deutschland.
authors.forename: J
authors.initials: J
authors.lastname: Leipe
authors.affiliation: Kerckhoff-Klinik, Bad Nauheim, Deutschland.
authors.forename: U
authors.initials: U
authors.lastname: Müller-Ladner
authors.affiliation: Universität Erlangen-Nürnberg, Erlangen, Deutschland.
authors.forename: J
authors.initials: J
authors.lastname: Rech
authors.affiliation: Medizinische Hochschule Hannover, Hannover, Deutschland.
authors.forename: E
authors.initials: E
authors.lastname: Riechers
authors.affiliation: Universitätsklinik Köln, Köln, Deutschland.
authors.forename: A
authors.initials: A
authors.lastname: Rubbert-Roth
authors.affiliation: Medizinische Hochschule Hannover, Hannover, Deutschland.
authors.forename: R E
authors.initials: RE
authors.lastname: Schmidt
authors.affiliation: Klinikum der Universität München, München, Deutschland.
authors.forename: H
authors.initials: H
authors.lastname: Schulze-Koops
authors.affiliation: St. Josef Krankenhaus Essen-Werden GmbH, Essen, Deutschland.
authors.forename: C
authors.initials: C
authors.lastname: Specker
authors.affiliation: Universitätsklinikum Carl Gustav Carus, Dresden, Deutschland.
authors.forename: A-K
authors.initials: AK
authors.lastname: Tausche
authors.affiliation: Rheumazentrum Ratingen, Ratingen, Deutschland.
authors.forename: S
authors.initials: S
authors.lastname: Wassenberg
authors.affiliation: Klinikum der Universität München, München, Deutschland.
authors.forename: M
authors.initials: M
authors.lastname: Witt
authors.affiliation: Medizinische Hochschule Hannover, Hannover, Deutschland.
authors.forename: T
authors.initials: T
authors.lastname: Witte
authors.affiliation: Charité-Universitätsmedizin, Berlin, Deutschland.
authors.forename: J
authors.initials: J
authors.lastname: Zernicke
authors.affiliation: Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie, Sandhöfer Allee 6, 60528, Frankfurt am Main, Deutschland.
authors.forename: H
authors.initials: H
authors.lastname: Burkhardt
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D000068456:Clinical Studies as Topic / Q000379:methods*; D005060:Europe; D005858:Germany; D006801:Humans; D018579:Patient Selection; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012219:Rheumatology / Q000458:organization & administration*; D016896:Treatment Outcome; D014481:United States
chemical_list: D018501:Antirheumatic Agents
keywords: Clinical research; Costs; Funding; Germany; Rheumatoid arthritis