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Clinical endpoints in oncology - a primer
Amanda Delgado1, Achuta Kumar Guddati1
1Division of Hematology/Oncology, Georgia Cancer Center, Augusta University GA 30912, Augusta.
American Journal of Cancer Research
|May 5, 2021
Summary
This review examines clinical endpoints for cancer therapy trials. It discusses overall survival (OS) and surrogate endpoints, evaluating their benefits and drawbacks for oncology research.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Clinical endpoints are crucial for evaluating cancer therapy safety and efficacy.
- Overall survival (OS) is the traditional gold standard but has limitations.
- Surrogate endpoints and quality of life measures are gaining importance in oncology trials.
Purpose of the Study:
- To review the roles of primary and surrogate clinical endpoints in cancer therapy assessment.
- To analyze the benefits and drawbacks of various clinical endpoints.
- To compare the unique features and applications of different endpoints.
Main Methods:
- Literature review of clinical endpoint utilization in oncology.
- Analysis of advantages and disadvantages of primary and surrogate endpoints.
- Comparative assessment of endpoint characteristics and their specific uses.
Main Results:
- Overall survival (OS) is a reliable but time-consuming endpoint.
- Surrogate endpoints offer faster trial results but require careful validation.
- Quality of life and treatment failure endpoints provide additional valuable insights.
Conclusions:
- The selection of clinical endpoints must balance trial efficiency with data integrity.
- Evolving cancer therapies necessitate adaptable and comprehensive endpoint strategies.
- Understanding the nuances of each endpoint is key to optimizing clinical trial design and interpretation.
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