CO4 Predictors of Inpatient Relapse in Multiple Sclerosis Patients Using First-Line Disease Modifying Therapies: A Machine Learning Study of Real World Data

2021 ◽  
Vol 24 ◽  
pp. S4-S5
Author(s):  
Z. Icten ◽  
M. Friedman ◽  
J. Menzin
Keyword(s):  
Machine Learning ◽  
Multiple Sclerosis ◽  
Real World ◽  
Learning Study ◽  
First Line ◽  
Real World Data ◽  
World Data ◽  
Disease Modifying Therapies ◽  
Disease Modifying ◽  
Multiple Sclerosis Patients

scholarly journals Italian multiple sclerosis register as the basis for post-authorization safety studies

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Ponzio ◽  
M Trojano ◽  
M Capobianco ◽  
M Pugliatti ◽  
M Ulivelli ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Pharmaceutical Industry ◽  
Real World ◽  
Treatment Effectiveness ◽  
Patient Registries ◽  
Real World Data ◽  
World Data ◽  
Disease Modifying Therapy ◽  
Disease Modifying

Abstract While the safety and efficacy of Disease Modifying Therapy (DMT) in multiple sclerosis (MS) are assessed in clinical trials, these are of relatively short duration and always confined to highly selected patient groups. The evaluation of real-world data such as patient registries, is vital as it offers long-term data collection and is patient rather than product-focused during the lifetime of MS, and allows to document a patient's treatment history throughout the disease course. Patient registries can play an important role in monitoring the safety of drus. Regulators and the pharmaceutical industry have shown interest in complementing or even replacing phase 4 clinical studies with data from MS registries. The Italian MS Register (IMSR), in collaboration with the Big MS Data initiative, that also includes the national MS registries of Denmark, France, and Sweden and the international database network MSBase, came together with industry to conduct studies on post-authorization safety (PASS) and treatment effectiveness. The IMSR includes the clinical history of approximately 55,000 patients, or approximatively 45% of the estimated cases of MS in Italy. More than 10,000 patients have a follow-up duration of over 10 years. A Core Protocol outlining principles of PASS projects was created in which aggregated results made available to sponsors and health authorities. The Core Protocol specifies variables, emphasizes improved capture of adverse events, in particular cancer, non-melanoma skin cancers and immunosuppression-related infections, all MedDRA-coded. EUROCAT codes for pregnancy outcomes are also documented. Regulators, the pharmaceutical industry and national-level registries have jointly identified a format of collaboration on PASS for DMT in MS to benefit patients and the larger society. In this way, we hope to contribute to a framework that will include emerging and existing registries with the common goal of contributing to the advancement of knowledge in MS. Key messages The real-world data can contribute to understanding of the impact of disease-modifying therapy on long term. A format of collaboration among clinical research, regulators and pharmaceutical industry could be a winning framework to improve the knowledge on safety and treatment effectiveness in MS.

scholarly journals Using Clinical Trial and Real World Data to Bridge Efficacy to Effectiveness of Fingolimod in Multiple Sclerosis Patients

2016 ◽  
Vol 19 (7) ◽  
pp. A426
Author(s):  
V Ivanov ◽  
R Torgovitsky ◽  
E Tchetgen Tchetgen ◽  
B Church ◽  
V Alas ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
Multiple Sclerosis Patients
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