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[Do we still need clinical studies in rheumatology?]
U Henkemeier1, R Alten2, B Bannert3
1Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie, Sandhöfer Allee 6, 60528, Frankfurt am Main, Deutschland. henkemeier@ciri-clinical.de.
Zeitschrift Fur Rheumatologie
|December 19, 2015
Summary
Despite available treatments, many rheumatic disease patients in Germany remain undertreated. This study explores strategies to optimize clinical trials in Germany, balancing cost-effectiveness with high-quality rheumatology research.
Area of Science:
- Rheumatology
- Clinical Trial Management
- Pharmaceutical Development
Background:
- Significant unmet medical needs exist in treating rheumatic and immune-mediated diseases.
- Current therapies inadequately treat 15-40% of rheumatoid arthritis patients in Germany.
- Drug development faces high costs and low recruitment in traditional regions like Western Europe.
Purpose of the Study:
- To identify arguments for conducting clinical trials in Western Europe, specifically Germany.
- To propose solutions for optimizing clinical trial conduct and compensation in German study centers.
- To address the need for innovative therapies in rheumatology.
Main Methods:
- Discussion of arguments favoring German sites for clinical trials.
- Analysis of cost-saving strategies in drug development.
- Exploration of recruitment rate challenges and solutions.
Main Results:
- Western Europe, particularly Germany, offers high data quality and infrastructure for clinical trials.
- Shifting trials to Eastern Europe, Latin America, and Asia is driven by lower costs and higher recruitment.
- Strong justifications exist for retaining and optimizing clinical trial conduct within Germany.
Conclusions:
- Germany presents compelling advantages for rheumatology clinical trials despite cost considerations.
- Strategic approaches are needed to ensure competitive and efficient trial execution in Germany.
- Optimizing German participation is crucial for advancing innovative rheumatology treatments.
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