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Joint recommendations on cost calculation and estimation in paediatric clinical trials
Gabriele Ahne1,2,3, Julia Nagel4, Axel R Franz5
1Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (IKP), Stuttgart, Germany.
German Medical Science : GMS E-Journal
|May 22, 2024
Summary
Conducting clinical trials in children requires higher costs due to specialized needs. This study developed a cost calculation template to ensure appropriate funding for pediatric clinical research.
Area of Science:
- Clinical Pharmacology
- Pediatric Research
- Health Economics
Background:
- Improving pediatric drug therapy necessitates high-quality clinical trials.
- European regulations (EU 536/2014, 745/2017) increase workload and costs for pediatric trials.
- Existing cost calculation methods do not fully account for the unique demands of pediatric research.
Purpose of the Study:
- To develop a cost calculation template specifically for pediatric clinical trials.
- To support pediatric study centers in accurately estimating costs and securing funding.
- To ensure appropriate remuneration for the increased workload in pediatric research.
Main Methods:
- A working group within the c4c/GermanNetPaeT network convened workshops.
- Developed a cost calculation template based on DHM, KKS Network, and vfa recommendations.
- Estimated time for specific measures in a sample pediatric study to identify cost drivers.
Main Results:
- A comprehensive cost calculation template tailored for pediatric trials was created.
- Identified specific pediatric-related aspects that increase trial costs and time.
- Provided a transparent framework for financial requirements for study centers and funders.
Conclusions:
- Accurate cost calculation is crucial for the successful and sustainable conduct of pediatric clinical trials.
- The developed template addresses the unique financial needs of pediatric research.
- Promoting understanding of higher costs aims to ensure long-term, high-quality pediatric clinical research.
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