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Joint recommendations for a total services account as a factor in simplifying contracts
Insa Bruns1, Carmen Schade-Brittinger2, Frank Wissing3
1Coordination Center for Clinical Studies (KKS-Netzwerk e.V.), Berlin, Germany.
German Medical Science : GMS E-Journal
|November 16, 2019
Summary
Germany is a leading European location for clinical trials, ranking third globally. To maintain competitiveness amidst declining trial numbers, streamlined contract negotiations and clear cost calculations for clinical trials are essential for timely drug development.
Area of Science:
- Clinical research and pharmaceutical development.
- Medical innovation and patient treatment.
- Healthcare economics and regulatory affairs.
Background:
- Clinical trials are crucial for translating basic research into patient treatments and represent a key area of medical advancement.
- Germany holds a strong international position in pharmaceutical clinical trials (2nd in Europe, 3rd globally).
- Maintaining Germany's competitiveness as a clinical trial location is vital for patients, research institutions, and the pharmaceutical industry.
Purpose of the Study:
- To address the declining number of clinical trials and ensure Germany remains competitive.
- To streamline contract negotiations and facilitate the early initiation of clinical trials.
- To provide practical recommendations for calculating the costs associated with conducting clinical trials.
Main Methods:
- Joint discussions among key stakeholders: German Association of Medical Faculties (MFT), German Association of Academic Medical Centers (VUD), Coordination Center for Clinical Studies (KKS-Netzwerk), and the German Association of Research-Based Pharmaceutical Companies (vfa).
- Development and publication of joint "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center."
- Analysis of recurring cost positions in clinical trial contracts to aid precise remuneration determination.
Main Results:
- The collaborative effort resulted in practical recommendations for calculating clinical trial costs.
- These recommendations aim to facilitate clearer and more efficient contract negotiations.
- The goal is to ensure fair remuneration and transparent coverage of business relationships in clinical trials.
Conclusions:
- Streamlined and transparent contract and budget agreements are essential for the timely initiation of clinical trials.
- The developed recommendations provide a framework for cost calculation, supporting Germany's position in clinical research.
- Continued collaboration and clear guidelines are necessary to foster a competitive environment for clinical trials in Germany.
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