Cargando…

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study

INTRODUCTION: Optimise:MS is an observational pharmacovigilance study aimed at characterizing the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in a real world population. The study will categorize and quantify the occurrence of serious adverse events (SAEs) in a c...

Descripción completa

Detalles Bibliográficos
Autores principales:	Waddingham, Ed, Miller, Aleisha, Dobson, Ruth, Matthews, Paul M.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Frontiers Media S.A. 2022
Materias:	Neurology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8996123/ https://www.ncbi.nlm.nih.gov/pubmed/35418938 http://dx.doi.org/10.3389/fneur.2022.799531

Ejemplares similares

OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis
por: Dobson, Ruth, et al.
Publicado: (2021)

Predicting Multiple Sclerosis: Challenges and Opportunities
por: Hone, Luke, et al.
Publicado: (2022)

National stroke management plan in Uruguay: Challenges and opportunities
por: Amorín, Ignacio, et al.
Publicado: (2023)

Assessing fracture risk in people with MS: a service development study comparing three fracture risk scoring systems
por: Dobson, Ruth, et al.
Publicado: (2013)

Family Planning in Fertile-Age Patients With Multiple Sclerosis (MS) (ConPlanEM Study): Delphi Consensus Statements
por: Oreja-Guevara, Celia, et al.
Publicado: (2023)

Progressive multifocal leukoencephalopathy genetic risk variants for pharmacovigilance of immunosuppressant therapies
por: Hatchwell, Eli, et al.
Publicado: (2022)

Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning
por: Zou, Min, et al.
Publicado: (2020)

Commentary: Progressive multifocal leukoencephalopathy genetic risk variants for pharmacovigilance of immunosuppressant therapies
por: Berger, Joseph R., et al.
Publicado: (2023)

Pharmacovigilance strategy: opportunities for cross-national learning
por: Fermont, Irene
Publicado: (2019)

Amyotrophic lateral sclerosis and the innate immune system: protocol for establishing a biobank and statistical analysis plan
por: Kjældgaard, Anne-Lene, et al.
Publicado: (2020)

Results of treatment with alemtuzumab in a Spanish cohort of patients with multiple sclerosis in the real world: The RealMS study
por: Eichau, Sara, et al.
Publicado: (2023)

Good multiple sclerosis (MS) care and how to get there in Canada: Perspectives of Canadian healthcare providers working with persons with MS
por: Petrin, Julie, et al.
Publicado: (2023)

Best Practices for Long-Term Monitoring and Follow-Up of Alemtuzumab-Treated MS Patients in Real-World Clinical Settings
por: Barclay, Krista, et al.
Publicado: (2019)

Lacosamide as the first add-on therapy in adult patients with focal epilepsy: A multicenter real-world study
por: Liu, Wenyu, et al.
Publicado: (2023)

Harnessing Real-World Data to Inform Decision-Making: Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
por: Mowry, Ellen M., et al.
Publicado: (2020)

vigiRank for statistical signal detection in pharmacovigilance: First results from prospective real‐world use
por: Caster, Ola, et al.
Publicado: (2017)

Switching to second line MS disease-modifying therapies is associated with decreased relapse rate
por: Marriott, James John, et al.
Publicado: (2023)

Safety, Adherence and Persistence in a Real-World Cohort of German MS Patients Newly Treated With Ocrelizumab: First Insights From the CONFIDENCE Study
por: Weber, Martin S., et al.
Publicado: (2022)

The Epidemiology of COVID-19 and MS-Related Characteristics in a National Sample of People With MS in China
por: Zhang, Yao, et al.
Publicado: (2021)

Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities
por: Lewis, David John, et al.
Publicado: (2019)

Teaching Pharmacovigilance to Healthcare Students: Identifying Gaps and Opportunities for Improvement
por: Seselja Perisin, Ana, et al.
Publicado: (2021)

Pharmacovigilance and spontaneous adverse drug reaction reporting: Challenges and opportunities
por: Desai, Mira
Publicado: (2022)

Economic Evaluation Protocol and Statistical Analysis Plan for the Cost-Effectiveness of a Novel Australian Stroke Telemedicine Program; the Victorian Stroke Telemedicine (VST) program
por: Cadilhac, Dominique A., et al.
Publicado: (2021)

Pregnancy and the Postpartum Period in Women With Relapsing-Remitting Multiple Sclerosis Treated With Old and New Disease-Modifying Treatments: A Real-World Multicenter Experience
por: Zanghì, Aurora, et al.
Publicado: (2020)

Valproate MHRA Guidance: Limitations and Opportunities
por: Watkins, Lance, et al.
Publicado: (2019)

Editorial: Preventing multiple sclerosis
por: Dobson, Ruth, et al.
Publicado: (2022)

Comparison of clinical outcomes in patients with acute ischemic stroke who underwent endovascular treatment using different perfusion modalities: a real-world multicenter study
por: Gao, Jiali, et al.
Publicado: (2023)

The challenging times and opportunities for pharmacovigilance in Africa during the COVID-19 pandemic
por: Ogar, C., et al.
Publicado: (2020)

Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities
por: Kugener, Veronique F., et al.
Publicado: (2021)

The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities
por: Chandler, Rebecca E.
Publicado: (2022)

Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature
por: Li, Yanping, et al.
Publicado: (2023)

Intrathecal B Cells in MS Have Significantly Greater Lymphangiogenic Potential Compared to B Cells Derived From Non-MS Subjects
por: Stein, Jason, et al.
Publicado: (2018)

Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping
por: D’Arcy, Shona, et al.
Publicado: (2017)

Planning and Providing Acute Stroke Care in England: The Effect of Planning Footprint Size
por: Allen, Michael, et al.
Publicado: (2019)

Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure
por: Hellwig, Kerstin, et al.
Publicado: (2020)

The Challenge and Opportunity to Diagnose Parkinson's Disease in Midlife
por: Kilzheimer, Alexander, et al.
Publicado: (2019)

Referral patterns after a seizure admission in an English region: an opportunity for effective intervention? An observational study of routine hospital data
por: Grainger, Ruth, et al.
Publicado: (2016)

New Oxford style manual: the world's most trusted reference books
por: Waddingham, Anne
Publicado: (2016)

Optimising acute stroke care organisation: a simulation study to assess the potential to increase intravenous thrombolysis rates and patient gains
por: Lahr, Maarten M H, et al.
Publicado: (2020)

Parkinson's Disease Research on the African Continent: Obstacles and Opportunities
por: Dekker, Marieke C. J., et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_aqrmkma7mh1dhpt5m52qr0vdo7