Abstract
ObjectiveRe-randomization trials allow patients to be re-enrolled for multiple treatment episodes. However, it remains uncertain to what extent re-randomization improves recruitment compared to parallel group designs or whether treatment estimates might be affected. Study Design and SettingWe evaluated trials included in a recent Cochrane review of granulocyte colony-stimulating factors for patients with febrile neutropenia. We assessed the recruitment benefits of re-randomization trials; compared treatment effect estimates between re-randomization and parallel group designs; and assessed whether re-randomization led to higher rates of non-compliance and loss to follow-up in subsequent episodes. ResultsWe included 14 trials (5 re-randomization and 9 parallel group). The re-randomization trials recruited a median of 25% (range 16–66%) more episodes on average than they would have under a parallel-group design. Treatment effect estimates were similar between re-randomization and parallel group trials across all outcomes, though confidence intervals were wide. The re-randomization trials in this review reported no loss to follow-up and low rates of non-compliance (median 1.7%, range 0–8.9%). ConclusionsIn the setting of febrile neutropenia, re-randomization increased recruitment while providing similar estimates of treatment effect to parallel group trials, with minimal loss to follow-up or non-compliance. It appears to be safe and efficient alternative to parallel group designs in this setting.
Highlights
Febrile neutropenia occurs when neutropenic patients develop fever
The number of times each patient is enrolled in the trial is not specified in advance, but instead depends on the number of febrile neutropenia episodes they experience during the course of the trial; some patients may be enrolled only once, and others may be enrolled multiple times
Of the trials that reported a sample size calculation, each based their calculation on a parallel group design
Summary
Overview of re-randomization trials neutropenia episodes may be ineligible for the trial, which can affect recruitment. An alternative approach is a re-randomization trial (Fig. 1) [2e4]. In re-randomization trials, patients can be re-enrolled and re-randomized for each new episode of febrile neutropenia they experience. The number of times each patient is enrolled in the trial is not specified in advance, but instead depends on the number of febrile neutropenia episodes they experience during the course of the trial; some patients may be enrolled only once, and others may be enrolled multiple times. Because patients can be enrolled for multiple episodes, re-randomization can increase the recruitment rate compared to parallel group designs, which could facilitate quicker and more efficient trials [2,3]
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