Sequential allocation to balance prognostic factors in a psychiatric clinical trial

Victor Fossaluza, Juliana Belo Diniz, Basilio de Bragança Pereira, Eurípedes Constantino Miguel, Carlos Alberto de Bragança Pereira, Victor Fossaluza, Juliana Belo Diniz, Basilio de Bragança Pereira, Eurípedes Constantino Miguel, Carlos Alberto de Bragança Pereira

Abstract

Objective: This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients.

Method: Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one.

Results: We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment.

Conclusion: Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov NCT00466609 and NCT00680602.

Keywords: Aitchison’s compositional distance; Clinical research; Randomization.

Figures

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Clinical study design

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