Universität zu Köln

Henkemeier, U., Alten, R., Bannert, B., Baraliakos, X., Behrens, F., Heldmann, F., Kiltz, U., Koehm, M., Koenig, R., Leipe, J., Mueller-Ladner, U., Rech, J., Riechers, E., Rubbert-Roth, A., Schmidt, R. E., Schulze-Koops, H., Specker, C., Tausche, A. -K, Wassenberg, S., Witt, M., Witte, T., Zernicke, J. and Burkhardt, H. (2016). Do we still need clinical studies in rheumatology? Z. Rheumatol., 75 (1). S. 4 - 11. HEIDELBERG: SPRINGER HEIDELBERG. ISSN 1435-1250

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Henkemeier, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Alten, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bannert, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baraliakos, X. UNSPECIFIED UNSPECIFIED UNSPECIFIED Behrens, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heldmann, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kiltz, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Koehm, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Koenig, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Leipe, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller-Ladner, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rech, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Riechers, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rubbert-Roth, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, R. E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schulze-Koops, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Specker, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tausche, A. -K UNSPECIFIED UNSPECIFIED UNSPECIFIED Wassenberg, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Witt, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Witte, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zernicke, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Burkhardt, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-285290
DOI:	10.1007/s00393-015-1687-x
Journal or Publication Title:	Z. Rheumatol.
Volume:	75
Number:	1
Page Range:	S. 4 - 11
Date:	2016
Publisher:	SPRINGER HEIDELBERG
Place of Publication:	HEIDELBERG
ISSN:	1435-1250
Language:	German
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28529