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Analysis of multiple failure time data from an AIDS clinical trial
D M Finkelstein1, D A Schoenfeld, E Stamenovic
1Biostatistics Department, Harvard School of Public Health, Boston, MA 02115, USA.
Statistics in Medicine
|April 30, 1997
Summary
This study addresses analyzing multiple infections and mortality in AIDS prophylaxis trials. It explores methods for combined endpoints, crucial for accurate treatment effect evaluation in HIV/AIDS research.
Area of Science:
- Clinical Trials Methodology
- Epidemiology
- Biostatistics
Background:
- Opportunistic infections are primary endpoints in AIDS prophylaxis trials.
- Treatments may impact mortality, necessitating combined endpoint analysis.
- Existing methods for multiple failure time data lack standardization for mortality inclusion.
Purpose of the Study:
- To explore statistical methods for analyzing multiple infections and mortality in AIDS clinical trials.
- To address the need for a standard method combining infection and survival data.
- To apply these methods to a real-world AIDS prophylaxis trial.
Main Methods:
- Analysis of multiple failure time data.
- Development and application of methods for combined infection and mortality endpoints.
- Utilizing statistical techniques for complex event data in clinical research.
Main Results:
- The study investigates the impact of treatments on both infection occurrence and survival.
- Exploration of analytical approaches for trials where mortality is a potential treatment effect.
- Application to an AIDS clinical trial for fungal infection prophylaxis.
Conclusions:
- Combined analysis of infection and survival is essential for AIDS prophylaxis trials.
- The explored methods provide a framework for evaluating treatments with potential mortality effects.
- This research contributes to robust statistical practices in HIV/AIDS clinical studies.