Universität zu Köln

Kron, F., Kostenko, A., Scheffler, M., Mueller, D., Glossmann, J. -P., Fischer, R., Michels, S., Nogova, L., Hallek, M., Zander, T. and Wolf, J. (2017). Economic burden of clinical trials in lung cancer in a German Comprehensive Cancer Center. Lung Cancer, 108. S. 134 - 140. CLARE: ELSEVIER IRELAND LTD. ISSN 1872-8332

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Abstract

Objectives: The recent success of individualized lung cancer therapy has triggered fundamental changes in clinical research strategies. To date there is a strong focus on early proof of concept trials in genetically preselected small patient subgroups. This analysis focuses on the economic burden caused by such trials for advanced lung cancer patients in a German Comprehensive Cancer Center (CCC). Methods: The profit margins between recruiting groups with <= 3 and >3 patients were compared. Clinical and economic data from clinical trials for advanced lung cancer (LC), pharma-sponsored trials (PhST) as well as investigator initiated trials (IIT), conducted between 2011 and 2015 at the Center for Integrated Oncology (CIO) Cologne, were analyzed using a profit-center calculation model. Results: 161 patients were enrolled in 27 clinical trials. The key economic parameter determining costs and payments was the 'trial visits'. In comparison of the two groups (A <= 3; B>3 patients enrolled) we found negative profit margins for the low recruiting group (sic -1444). Concerning the number of visits significant differences were found between PhST and IIT (p= 0.009). Additionally, sub-analysis show structural differences in cost composition by conducting PhST and IIT. Conclusion: Trials with low patient numbers and IIT, do not cover the cost. To ensure adequate, cost covering compensation by pharmaceutical companies CCCs have to thoroughly calculate the cost of early proof of concept trials. The findings of this study also underline the need for novel structures in public funding for investigator-initiated clinical trials in precision medicine. (C) 2017 Elsevier B.V. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kron, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kostenko, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Scheffler, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Glossmann, J. -P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischer, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Michels, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nogova, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zander, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-228502
DOI:	10.1016/j.lungcan.2017.03.018
Journal or Publication Title:	Lung Cancer
Volume:	108
Page Range:	S. 134 - 140
Date:	2017
Publisher:	ELSEVIER IRELAND LTD
Place of Publication:	CLARE
ISSN:	1872-8332
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language COST-EFFECTIVENESS; 1ST-LINE TREATMENT; THERAPY; ADENOCARCINOMA; CARE Multiple languages Oncology; Respiratory System Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22850