Surrogate endpoints for EDSS worsening in multiple sclerosis: A meta-analytic approach

Neurology ◽  
2010 ◽  
Vol 75 (4) ◽  
pp. 302-309 ◽  
Author(s):  
M. P. Sormani ◽  
L. Bonzano ◽  
L. Roccatagliata ◽  
G. L. Mancardi ◽  
A. Uccelli ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Analytic Approach ◽  
Surrogate Endpoints

Surrogate endpoints for EDSS worsening in multiple sclerosis: A meta-analytic approach: Measuring disability in relapsing-remitting MS

Neurology ◽  
2011 ◽  
Vol 76 (11) ◽  
pp. 1025-1026 ◽  
Author(s):  
G. C. Ebers ◽  
M. Daumer ◽  
A. Scalfari ◽  
R. Rudick ◽  
L. Kappos ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Analytic Approach ◽  
Surrogate Endpoints ◽  
Relapsing Remitting

Prognostic factors versus markers of response to treatment versus surrogate endpoints: Three different concepts

2017 ◽  
Vol 23 (3) ◽  
pp. 378-381 ◽  
Author(s):  
Maria Pia Sormani
Keyword(s):  
Multiple Sclerosis ◽  
Prognostic Factors ◽  
Quantitative Assessment ◽  
Prognostic Markers ◽  
Response To Treatment ◽  
Surrogate Endpoints ◽  
Surrogate Markers ◽  
Methodological Issues ◽  
Baseline Factors

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 response to treatments and of surrogate endpoints, is crucial in multiple sclerosis research. Aim of this report is to clarify some basic definitions and methodological issues about baseline factors to be considered prognostic markers or markers of response to treatment; to define the dynamic role that variables must have to be considered surrogate markers in relation to specific treatments.

Magnetic resonance imaging as a potential surrogate for relapses in multiple sclerosis: A meta-analytic approach

2009 ◽  
Vol 65 (3) ◽  
pp. 268-275 ◽  
Author(s):  
Maria Pia Sormani ◽  
Laura Bonzano ◽  
Luca Roccatagliata ◽  
Gary R. Cutter ◽  
Gian Luigi Mancardi ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Multiple Sclerosis ◽  
Magnetic Resonance ◽  
Analytic Approach ◽  
Resonance Imaging

A systematic review of factors associated with accidental falls in people with multiple sclerosis: a meta-analytic approach

2014 ◽  
Vol 28 (7) ◽  
pp. 704-716 ◽  
Author(s):  
Costanza Giannì ◽  
Luca Prosperini ◽  
Johanna Jonsdottir ◽  
Davide Cattaneo
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Accidental Falls ◽  
Analytic Approach ◽  
Factors Associated

Magnetic resonance imaging as surrogate for clinical endpoints in multiple sclerosis: data on novel oral drugs

2010 ◽  
Vol 17 (5) ◽  
pp. 630-633 ◽  
Author(s):  
MP Sormani ◽  
L Bonzano ◽  
L Roccatagliata ◽  
N De Stefano
Keyword(s):  
Magnetic Resonance Imaging ◽  
Multiple Sclerosis ◽  
Magnetic Resonance ◽  
Surrogate Endpoints ◽  
Novel Therapies ◽  
Resonance Imaging ◽  
Disability Progression ◽  
Oral Drugs ◽  
Clinical Endpoints ◽  
Magnetic Resonance Imaging Mri

Recent studies have provided evidence for using magnetic resonance imaging (MRI) active lesions as surrogate for relapses and disability progression in multiple sclerosis (MS). However, the validity of MRI metrics as surrogate endpoints in MS is controversial. Furthermore, the extrapolation of previous results to novel therapies is not warranted. We tested here the validity of MRI surrogacy in MS studies on recently published trials of oral drugs. The 92% of observed effects of oral drugs on clinical outcomes resulted close to those predicted by MRI active lesions. This further validates MRI surrogacy in MS, with important implications for future trials planning.

Meta-Analytic Approach to Evaluation of Surrogate Endpoints

2020 ◽  
pp. 457-478
Author(s):  
Tomasz Burzykowski ◽  
Marc Buyse ◽  
Geert Molenberghs ◽  
Ariel Alonso ◽  
Wim Van der Elst ◽  
...  
Keyword(s):  
Analytic Approach ◽  
Surrogate Endpoints

Social cognition and executive functioning in multiple sclerosis: A cluster‐analytic approach

2021 ◽  
Author(s):  
Audrey Henry ◽  
Séverine Lannoy ◽  
Marie‐Pierre Chaunu ◽  
Ayman Tourbah ◽  
Michèle Montreuil
Keyword(s):  
Multiple Sclerosis ◽  
Social Cognition ◽  
Executive Functioning ◽  
Analytic Approach ◽  
Cluster Analytic

Implementing the meta-analytic approach for the evaluation of surrogate endpoints in SAS and R: a word of caution

2021 ◽  
pp. 1-12
Author(s):  
Fenny Ong ◽  
Jingzhao Wang ◽  
Wim Van der Elst ◽  
Geert Verbeke ◽  
Geert Molenberghs ◽  
...  
Keyword(s):  
Analytic Approach ◽  
Surrogate Endpoints

scholarly journals Outcome Measures in Relapsing-Remitting Multiple Sclerosis: Capturing Disability and Disease Progression in Clinical Trials

2014 ◽  
Vol 2014 ◽  
pp. 1-13 ◽  
Author(s):  
Amy M. Lavery ◽  
Leonard H. Verhey ◽  
Amy T. Waldman
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Neurodegenerative Disease ◽  
Disease Progression ◽  
Outcome Measures ◽  
Primary Endpoint ◽  
Surrogate Endpoints ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that manifests as acute relapses and progressive disability. As a primary endpoint for clinical trials in MS, disability is difficult to both characterize and measure. Furthermore, the recovery from relapses and the rate of disability vary considerably among patients. Given these challenges, investigators have developed and studied the performance of various outcome measures and surrogate endpoints in MS clinical trials. This review defines the outcome measures and surrogate endpoints used to date in MS clinical trials and presents challenges in the design of both adult and pediatric trials.

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