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Published on: April 20, 2018
Endpoints and cutpoints in head and neck oncology trials: methodical background, challenges, current practice and
Marcus Hezel1, Kathrin von Usslar2, Thiemo Kurzweg3
1Department of Otorhinolaryngology, Head and Neck Surgery and Oncology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. m.hezel@uke.de.
This review covers the methodical and statistical foundations for clinical trial design, emphasizing endpoint selection for evidence-based medicine and head and neck cancer research.
Area of Science:
- Clinical Research Methodology
- Biostatistics
- Evidence-Based Medicine
Background:
- Significant advancements in head and neck cancer treatment have been made.
- Treatment goals vary based on factors like tumor stage.
- Clinical trial outcomes are measured using specific endpoints.
Purpose of the Study:
- To review the methodical and statistical basics of clinical trial design.
- To focus on defining and selecting endpoints and cutpoints.
- To highlight the importance of various endpoints in clinical research.
Main Methods:
- The study is based on electronic research.
- It focuses on the methodical and statistical foundations of clinical trials.
- It examines study designs and the presentation of endpoints.
Main Results:
- Endpoints are crucial for measuring treatment outcomes in clinical trials.
- Classical endpoints include overall survival and organ preservation.
- Quality of life endpoints are increasingly important in trial design.
Conclusions:
- Proper definition and selection of endpoints are fundamental to clinical research.
- Understanding trial design and endpoint selection is key for evidence-based medicine.
- The review provides a solid foundation for designing and conducting clinical trials.
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