Sortition - Participant Randomisation Software from the University of Oxford

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• published: 22 May 2015
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Interested in more details? contact Isis Innovation: james.groves@isis.ox.ac.uk Or click on: http://www.phc.ox.ac.uk/news/sortition-r-a-new-solution-for-managing-online-randomisation Sortition A stand-alone, online randomisation system builder that supports the standard randomisation and minimisation algorithms for both open and blind studies. The tool incorporates full auditing, user management, email notifications, treatment resource management, reporting and monitoring. Why randomise? Randomisation is an essential tool for clinical and life science researchers. For example, in a clinical trial, subjects in the control and treatment groups should not differ in any systematic way or the results will be biased. For instance, if a greater proportion of older subjects are assigned to the treatment group, then the outcome of treatment may be influenced by this imbalance. Researchers therefore need to control for factors such as age, sex, pre-existing medical conditions and treatments (such as medication), as well as other factors such as smoking/non-smoking, alcohol consumption, fitness, etc. A second layer of randomisation is then required to avoid selection bias when allocating patients to a treatment or control group. This can occur if there is any knowledge as to which group a patient is being assigned to, and again may affect the results. It is therefore important that allocation is concealed from the system. Randomisation strategies Clearly, randomisation in clinical trial settings is unfortunately not as simple as tossing a coin. A wide range of statistical methods (eg simple, block, stratified, and covariate adaptive methods) have been developed to allow proper and effective randomisation, each with their own advantages and disadvantages, and often complex to apply. A simple, flexible and scalable approach Sortition® puts a complete and easy-to-use study randomisation toolkit in the hands of the clinical researcher, meaning it no longer needs to fall within the remit of a highly skilled statistician. The system comes complete with secure user management, a full audit trail, email notifications and all the reporting and monitoring tools you would expect. Sortition® is currently in use in a growing number of trials. Key advantages Sortition® offers the following benefits: clean, uncluttered interface accessible over the internet wide range of powerful randomisation and minimisation methods works for both open and blind studies fully customisable and scalable full audit trail secure user management email notifications built-in treatment resource management, reporting and monitoring tools