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Competing risk analysis of life table data: application to lifetime risk computation
M H Dong1, S D Dubey, R T O'Neill
1Division of Biometrics, U.S. Food and Drug Administration, Rockville, MD 20857.
Journal of Clinical Epidemiology
|January 1, 1990
Summary
This study introduces two lifetime risks to assess treatment safety and risk exposure effects, accounting for competing risks. These computable risks are demonstrated using clinical study data.
Area of Science:
- Biostatistics
- Clinical Trials
- Toxicology
Background:
- Assessing treatment safety and chronic risk exposure requires robust statistical methods.
- Existing methods may not fully account for competing risks over a lifetime.
- Life table data is crucial for longitudinal risk assessment.
Purpose of the Study:
- To propose and detail computational procedures for two lifetime risks.
- To assess treatment safety in clinical trials using lifetime risks.
- To evaluate the effect of risk exposure in animal studies considering competing risks.
Main Methods:
- Development of computational procedures for two lifetime risks.
- Utilizing life table data to compute risks.
- Accounting for the impact of competing risks in calculations.
- Implementation in a computer program for practical application.
Main Results:
- Demonstration of detailed computational procedures for lifetime risks.
- Illustration of practical application using actual clinical study data.
- Validation of the proposed risk assessment method.
Conclusions:
- The proposed two lifetime risks provide a framework for evaluating safety and risk.
- Computational implementation is essential for the practical application of these risks.
- This method offers a comprehensive approach to risk assessment in clinical and animal studies.