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. 2018 May;97:14–19. doi: 10.1016/j.jclinepi.2018.02.002

Table 1.

Overview of re-randomization trials

Settings requirements for re-randomization trials
  • 1)

    Some patients may require treatment on multiple occasions

  • 2)

    The intervention(s) would be used for each new treatment episode

  • 3)

    The intervention duration and length of the follow-up period for each treatment episode are less than the overall length of the trial recruitment period

Design requirements for re-randomization trials
  • 1)

    Patients are only reenrolled and rerandomized when they have completed the follow-up period from their previous randomization

  • 2)

    Randomizations for the same patient are performed independently

Implementation of re-randomization trials
  • 1)

    Patients are enrolled as usual, randomized to a treatment group, and followed up until all outcomes have been collected

  • 2)

    If patients experience new treatment episodes and require further treatment, they can be reenrolled and rerandomized, provided they have completed the follow-up period from their previous randomization

  • 3)

    This process is repeated until the target sample size is met

Reproduced from Kahan BC. Using re-randomization to increase the recruitment rate in clinical trials–an assessment of three clinical areas. Trials. 2016;17:595. doi:10.1186/s13063-016-1736-z with permission.