### Abstract

Using multiple historical trials with surrogate and true endpoints, we consider various models to predict the effect of treatment on a true endpoint in a target trial in which only a surrogate endpoint is observed. This predicted result is computed using (1) a prediction model (mixture, linear, or principal stratification) estimated from historical trials and the surrogate endpoint of the target trial and (2) a random extrapolation error estimated from successively leaving out each trial among the historical trials. The method applies to either binary outcomes or survival to a particular time that is computed from censored survival data. We compute a 95% confidence interval for the predicted result and validate its coverage using simulation. To summarize the additional uncertainty from using a predicted instead of true result for the estimated treatment effect, we compute its multiplier of standard error. Software is available for download.

Original language | English (US) |
---|---|

Pages (from-to) | 248-257 |

Number of pages | 10 |

Journal | Biometrics |

Volume | 68 |

Issue number | 1 |

DOIs | |

State | Published - Mar 1 2012 |

### Fingerprint

### Keywords

- Principal stratification
- Randomized trials
- Reproducibility

### ASJC Scopus subject areas

- Statistics and Probability
- Biochemistry, Genetics and Molecular Biology(all)
- Immunology and Microbiology(all)
- Agricultural and Biological Sciences(all)
- Applied Mathematics

### Cite this

*Biometrics*,

*68*(1), 248-257. https://doi.org/10.1111/j.1541-0420.2011.01646.x