Lessons Learned from Phase II and Phase III Trials Investigating Therapeutic Agents for Cerebral Ischemia Associated with Aneurysmal Subarachnoid Hemorrhage
Author:
Publisher
Springer Science and Business Media LLC
Subject
Critical Care and Intensive Care Medicine,Neurology (clinical)
Link
https://link.springer.com/content/pdf/10.1007/s12028-021-01372-4.pdf
Reference120 articles.
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2. Macdonald RL, Higashida RT, Keller E, et al. Clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid haemorrhage undergoing surgical clipping: a randomised, double-blind, placebo-controlled phase 3 trial (CONSCIOUS-2). Lancet Neurol. 2011;10:618–25.
3. Dorhout Mees SM, Algra A, Vandertop WP, et al. Magnesium for aneurysmal subarachnoid haemorrhage (MASH-2): a randomised placebo-controlled trial. Lancet. 2012;380:44–9.
4. Wason JMS, Robertson DS. Controlling type I error rates in multi-arm clinical trials: A case for the false discovery rate. Pharm Stat. 2021;20:109–16.
5. 22 case studies where phase 2 and phase 3 trials had divergent results. 2017. (Accessed January 19, 2020, at https://www.fda.gov/media/102332/download.)
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