Using the bootstrap for estimation in group sequential designs: an application to a clinical trial for nasopharyngeal cancer

Stat Med. 1999 Oct 15;18(19):2635-44. doi: 10.1002/(sici)1097-0258(19991015)18:19<2635::aid-sim200>3.0.co;2-7.

Abstract

We investigate a resampling method for bias correction in group sequential designs with censored survival data using logrank testing. The method draws nested bootstrap samples of different sizes from the observed data in order to mimic the large sample independent increment property of statistics resulting from sequential designs. The motivation for this problem came from the very positive results and early termination of a randomized clinical trial for nasopharyngeal cancer co-ordinated by the Southwest Oncology Group.

MeSH terms

  • Antimetabolites, Antineoplastic / therapeutic use
  • Antineoplastic Agents / therapeutic use
  • Bias
  • Cisplatin / therapeutic use
  • Combined Modality Therapy
  • Data Interpretation, Statistical*
  • Fluorouracil / therapeutic use
  • Humans
  • Nasopharyngeal Neoplasms / drug therapy*
  • Nasopharyngeal Neoplasms / mortality
  • Nasopharyngeal Neoplasms / radiotherapy*
  • Randomized Controlled Trials as Topic / methods*
  • Research Design*
  • Survival Analysis

Substances

  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents
  • Cisplatin
  • Fluorouracil