An overview of statistical methods for multiple failure time data in clinical trials

Stat Med. 1997 Apr 30;16(8):833-9; discussion 841-51. doi: 10.1002/(sici)1097-0258(19970430)16:8<833::aid-sim538>;2-2.


In a long term clinical trial to evaluate a new treatment, quite often each study subject may experience a number of 'failures' that correspond to repeated occurrences of the same type of event or events of entirely different natures during his/her follow-up period. To obtain efficient inference procedures for the therapeutic effect over time, it is desirable to utilize those multiple event times in the analysis. In this article, we review some useful procedures for analysing different kinds of multivariate failure time data. Specifically, we discuss the two-sample problems and the general regression problems with various survival models. We also give some recommendations of appropriate procedures for each type of multiple event data structure for practical usage.

Publication types

  • Comparative Study

MeSH terms

  • Humans
  • Models, Statistical*
  • Multivariate Analysis
  • Randomized Controlled Trials as Topic / methods*
  • Recurrence
  • Time Factors
  • Treatment Failure