EMA Workshop

MEDICAL TRIALS

Posted on February 9, 2015 by NMO-UK — No Comments ↓

The Regulatory Workshop on Clinical Trials Designs

The Regulatory Workshop on Clinical Trials Designs in Neuromyelitis Optica (NMO) and Spectrum Disorders brought together patient representatives, healthcare professionals, regulators, pharma and ethicists to discuss trial designs in neuromyelitis optica (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.

 

  • 1. Welcome and Introduction
  • 2. Session 1, Population
  • 3. Session 1, Natural History
  • 4. Session 1, Diagnosis: New Criteria
  • 5. Session 1, Discussion
  • 6. Session 1, Current Standard of Care - clinical view
  • 7. Session 1, Current standard of Care - industry view
  • 8. Session 2, Consideration for Non Placebo/Add on Clinical Trial Designs for NMO
  • 9. Session 2, Consideration for Placebo Clinical Trial Designs for NMO
  • 10. Session 2, Detailed methods to manage risk in a placebo trial
  • 11. Session 2, Patient’s view
  • 12. Session 2, Discussion
  • 13. Session 2, The Ethical Consideration of Placebo Study Design in NMO
  • 14. Session 2, FDA view
  • 15. Session 2, EMA View
  • 16. Session 2, EU Clinical view
  • 17. Session 2, Discussion
  • 18. Session 3, Endpoints - clinical view
  • 19. Session 3, Endpoints - industry
  • 20. Session 3, Discussion
  • 21. Session 4, Development of drugs in paediatric NMO - clinical
  • 22. Session 4, Development of drugs in paediatric NMO - industry
  • 23. Session 4, Discussion
  • 24. Exit poll results and Wrap up

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