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Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials.

Publication ,  Journal Article
Lunceford, JK; Davidian, M; Tsiatis, AA
Published in: Biometrics
March 2002

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

Published In

Biometrics

DOI

ISSN

0006-341X

Publication Date

March 2002

Volume

58

Issue

1

Start / End Page

48 / 57

Location

England

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

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Lunceford, J. K., Davidian, M., & Tsiatis, A. A. (2002). Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials. Biometrics, 58(1), 48–57. https://doi.org/10.1111/j.0006-341x.2002.00048.x
Lunceford, Jared K., Marie Davidian, and Anastasios A. Tsiatis. “Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials.Biometrics 58, no. 1 (March 2002): 48–57. https://doi.org/10.1111/j.0006-341x.2002.00048.x.
Lunceford, Jared K., et al. “Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials.Biometrics, vol. 58, no. 1, Mar. 2002, pp. 48–57. Pubmed, doi:10.1111/j.0006-341x.2002.00048.x.
Journal cover image

Published In

Biometrics

DOI

ISSN

0006-341X

Publication Date

March 2002

Volume

58

Issue

1

Start / End Page

48 / 57

Location

England

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