Time for the Next Step in Clinical Trial Evolution?
- PMID: 36976460
- DOI: 10.1002/ana.26655
Time for the Next Step in Clinical Trial Evolution?
Comment on
-
Ravulizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder.Ann Neurol. 2023 Jun;93(6):1053-1068. doi: 10.1002/ana.26626. Epub 2023 Apr 5. Ann Neurol. 2023. PMID: 36866852
References
-
- Pittock SJ, Barnett M, Bennett JL, et al. Ravulizumab in Aquaporin-4-positive Neuromyelitis Optica Spectrum disorder. Ann Neurol 2023;93:1053-1068. https://doi.org/10.1002/ana.26626
-
- Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in Aquaporin-4-positive Neuromyelitis Optica Spectrum disorder. N Engl J Med 2019;381:614-625.
-
- International Conference on Harmonization (ICH) E10: Choice of control group and related issues in clinical trials. May, 2021, https://www.fda.gov/media/71349/download.
-
- Jahanshahi M, Gregg K, Davis G, et al. The use of external controls in FDA regulatory decision making. Ther Innov Regul Sci 2021;55:1019-1035.
-
- He A, Merkel B, Brown JWL, et al. Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study. Lancet Neurol 2020;19:307-316.
Publication types
LinkOut - more resources
Full Text Sources