Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials.
Some clinical trials follow a design where patients are randomized to a primary therapy at entry followed by another randomization to maintenance therapy contingent upon disease remission. Ideally, analysis would allow different treatment policies, i.e., combinations of primary and maintenance therapy if specified up-front, to be compared. Standard practice is to conduct separate analyses for the primary and follow-up treatments, which does not address this issue directly. We propose consistent estimators for the survival distribution and mean restricted survival time for each treatment policy in such two-stage studies and derive large-sample properties. The methods are demonstrated on a leukemia clinical trial data set and through simulation.
Duke Scholars
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Related Subject Headings
- Treatment Outcome
- Survival Analysis
- Statistics & Probability
- Randomized Controlled Trials as Topic
- Models, Statistical
- Leukemia, Myeloid, Acute
- Humans
- Granulocyte-Macrophage Colony-Stimulating Factor
- Computer Simulation
- Aged
Citation
Published In
DOI
ISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Treatment Outcome
- Survival Analysis
- Statistics & Probability
- Randomized Controlled Trials as Topic
- Models, Statistical
- Leukemia, Myeloid, Acute
- Humans
- Granulocyte-Macrophage Colony-Stimulating Factor
- Computer Simulation
- Aged