Journal
BIOMETRICS
Volume 58, Issue 1, Pages 48-57Publisher
INTERNATIONAL BIOMETRIC SOC
DOI: 10.1111/j.0006-341X.2002.00048.x
Keywords
induction therapy; intent to treat; inverse weighting; maintenance therapy; potential outcomes; survival analysis
Funding
- NATIONAL CANCER INSTITUTE [R01CA085848, R03CA051692] Funding Source: NIH RePORTER
- NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES [R01AI031789] Funding Source: NIH RePORTER
- NCI NIH HHS [R01-CA85848, R01-CA51692] Funding Source: Medline
- NIAID NIH HHS [R01-AI31789] Funding Source: Medline
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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-tip treatments, which does not address this issue directly. We propose consistent estimators for the survival distribution and mean restricted survival tune 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.
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