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Updated: Jan 29, 2026
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Endpoints in oncology clinical trials.
Saadettin Kilickap1, Umut Demirci, Nuri Karadurmus
1Hacettepe University Faculty of Medicine, Department of Medical Oncology, Ankara, Turkey.
Summary
Choosing the right endpoint in oncology clinical trials is crucial. This review examines various endpoints, considering overall survival
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Cancer treatment advances have led to improved survival outcomes.
- Overall survival is the gold standard endpoint but has limitations.
- Limitations include long follow-up, large patient numbers, and high costs.
Purpose of the Study:
- To review and discuss various endpoints used in oncology clinical trials.
- To address the question of selecting the most appropriate endpoint.
- To provide insights into endpoint selection for clinical benefit demonstration.
Main Methods:
- Literature review of oncology clinical trials.
- Discussion of primary and secondary endpoints.
- Analysis of endpoint advantages and disadvantages.
Main Results:
- Multiple endpoints exist for oncology clinical trials.
- Overall survival is a widely accepted but resource-intensive endpoint.
- Alternative endpoints may offer advantages in specific contexts.
Conclusions:
- Endpoint selection in oncology trials requires careful consideration.
- Balancing clinical benefit demonstration with practical constraints is key.
- The choice of endpoint impacts trial design, duration, and cost.
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