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01-01-2014 | Original Article

Randomization in clinical trials: stratification or minimization? The HERMES free simulation software

Authors: Hélène Fron Chabouis, Francis Chabouis, Florence Gillaizeau, Pierre Durieux, Gilles Chatellier, N. Dorin Ruse, Jean-Pierre Attal

Published in: Clinical Oral Investigations | Issue 1/2014

Abstract

Objectives

Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques.

Materials and methods

The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial.

Results

Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed.

Conclusions

A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge.

Clinical relevance

This software will help investigators choose the appropriate randomization method in future two-arm trials.

Available only for authorised users

This software can be downloaded at the following address: chabouis.fr/helene/hermes

We could also do a simple sum of the absolute imbalance values, but this method allowed us to penalize more serious imbalances. [39]

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Title: Randomization in clinical trials: stratification or minimization? The HERMES free simulation software
Authors: Hélène Fron Chabouis
Francis Chabouis
Florence Gillaizeau
Pierre Durieux
Gilles Chatellier
N. Dorin Ruse
Jean-Pierre Attal
Publication date: 01-01-2014
Publisher: Springer Berlin Heidelberg
Published in: Clinical Oral Investigations / Issue 1/2014
Print ISSN: 1432-6981
Electronic ISSN: 1436-3771
DOI: https://doi.org/10.1007/s00784-013-0949-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Randomization in clinical trials: stratification or minimization? The HERMES free simulation software

Abstract

Objectives

Materials and methods

Results

Conclusions

Clinical relevance

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objectives

Materials and methods

Results

Conclusions

Clinical relevance

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