Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders

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TitleRegulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders
Date10/10/2014 - 10/10/2014
LocationEuropean Medicines Agency, London, UK
SummaryThis workshop brings together patient representatives, healthcare professionals, regulators, Pharma and ethicists to discuss trial designs in NMO, a rare neurological disorder. For evidence of efficacy, in NMO, the choice of comparator is problematic. The severity/lack of reversibility of NMO relapses, indicate that placebo comparators are difficult but evidence for current treatments appears lacking. Different regulatory agencies have different views on comparators in NMO attack prevention. For a rare debilitating disease with unmet medical need, a wider debate is being held to facilitate drug development for the benefit of NMO patients. See 'Documents’ tab for agenda and 'Multimedia' tab for video of the workshop.

All documents

Name Language First published Last updated
Agenda - Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders (English only) 07/07/2014 07/10/2014
Registration form - Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders (English only) 07/07/2014  
Speaker biographies - Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders (English only) 23/10/2014  
Presentation - Setting the scene: Neuromyelitis optica (Jackie Palace) (English only) 23/10/2014  
Presentation - Natural history of neuromyelitis optica (Friedemann Paul) (English only) 23/10/2014  
Presentation - Diagnostic criteria for neuromyelitis optica 2014 (Brian G. Weinshenker) (English only) 23/10/2014  
Presentation - Clinical view on current standard of care in NMO (R. Marignier) (English only) 23/10/2014  
Presentation - Neuromyelitis optica – Is there a standard of care?(Eliezer Katz) (English only) 23/10/2014  
Presentation - Non-Placebo and Add on Clinical Trials (Warren W Wasiewski) (English only) 23/10/2014  
Presentation - Neuromyelitis optica: Is there treatment equipoise? (Bruce Cree) (English only) 23/10/2014  
Presentation - Methods to manage risk in a placebo trial (Susan VanMeter, Sarah Kavanagh) (English only) 23/10/2014  
Presentation - Neuromyelitis optica (NMO) testimonial - Speech (Irene Wilson) (English only) 23/10/2014  
Presentation - Neuromyelitis optica (NMO) testimonial (Irene Wilson) (English only) 23/10/2014  
Presentation - The ethics of placebo controlled studies - Speech (Simon Woods) (English only) 23/10/2014  
Presentation - Clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders - United States Perspective (Wiley A. Chambers) (English only) 23/10/2014  
Presentation - The ethical considerations of placebo study design in neuromyelitis optica (NMO) (MM Rosa) (English only) 23/10/2014  
Presentation - Clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders - EU clinical view (M Isabel Leite) (English only) 23/10/2014  
Presentation - Endpoints in a treatment trial in neuromyelitis optica (NMO) - Clinician’s view (Anu Jacob) (English only) 23/10/2014  
Presentation - Clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders - Endpoints Industry (Ayesh Perera) (English only) 23/10/2014  
Presentation - Development of drugs for paediatric neuromyelitis optica (NMO) (Cheryl Hemingway) (English only) 23/10/2014  
Presentation - Development of drugs in paediatric neuromyelitis optica (NMO) / neuromyelitis optica spectrum disorders (NMOSD) - Industry perspective (Josephine Glover) (English only) 23/10/2014  

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