SORMANI , Maria Pia

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Multiple sclerosis is a highly heterogeneous disease; the quantitative assessment of disease progression is problematic for many reasons, including the lack of objective methods to measure disability and the long follow-up times needed to detect relevant and stable changes. For these reasons, the importance of prognostic markers, markers of...

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Subgroup analysis is often conducted as a post-hoc evaluation of clinical trials. The aim of a subgroup analysis is the evaluation of the treatment effect that was tested in the trial, in a specific subgroups of patients. It can be run both on positive trials (to provide information about patients receiving the highest benefit from the...

Many therapeutic options are now available for patients with multiple sclerosis. While the efficacy of each drug has been assessed against placebo or, more recently, against interferon, no direct comparisons of these new therapies have been conducted in randomized clinical trials. Therefore, indirect treatment comparisons are needed to inform...

Demonstrating non-inferiority in clinical trials is usually more challenging than showing superiority. In multiple sclerosis (MS), non-inferiority trials are rarely designed since they would require prohibitive sample sizes. In this brief report, the reasons why non-inferiority trials are usually larger than superiority trials is explored

The calculation of the sample size needed for a clinical study is the challenge most frequently put to statisticians, and it is one of the most relevant issues in the study design. The correct size of the study sample optimizes the number of patients needed to get the result, that is, to detect the minimum treatment effect that is clinically...

The size of a treatment effect in clinical trials can be expressed in relative or absolute terms. Commonly used relative treatment effect measures are relative risks, odds ratios, and hazard ratios, while absolute estimate of treatment effect are absolute differences and numbers needed to treat. When making indirect comparisons of treatment...

The gold standard for measuring treatment effects is the randomized controlled trial. In patients with multiple sclerosis (MS), trial durations are typically 2-3 years, and the long-term effects of drugs for MS can only be assessed through trial extensions or observational studies that take advantage of data from registries or large...

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Multiple Sclerosis (MS) pathology is complex and includes inflammatory processes, neurodegeneration, and demyelination. While multiple drugs have been developed to tackle MS-related inflammation, to date there is scant evidence regarding which therapeutic approach, if any, could be used to reverse demyelination, foster tissue repair, and thus...

Background A meta-analysis of randomised trials in relapsing-remitting multiple sclerosis published in 2009 showed a quantitative relation between the treatment effects detected on MRI lesions and clinical relapses. We aimed to validate that relation using data from a large and independent set of clinical trials in multiple sclerosis. Methods...

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To assess whether it is feasible to establish specific cut-off values able to discriminate 'physiological' or 'pathological' brain volume rates in patients with multiple sclerosis (MS).

The occurrence or recurrence of autoimmune diseases or of autoantibodies (autoAb) has been reported during type I interferon (IFN) treatment.

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