Efficacy and safety of dexanabinol in severe traumatic brain injury: results of a phase III randomised, placebo-controlled, clinical trial

2006 ◽  
Vol 5 (1) ◽  
pp. 38-45 ◽  
Author(s):  
Andrew IR Maas ◽  
Gordon Murray ◽  
Herbert Henney ◽  
Nadim Kassem ◽  
Valerie Legrand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Severe Traumatic Brain Injury ◽  
Phase Iii ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety

scholarly journals The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

2018 ◽  
Vol 38 (5) ◽  
pp. 749-754 ◽  
Author(s):  
Olivia Kiwanuka ◽  
Bo-Michael Bellander ◽  
Anders Hånell
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Brain Injury ◽  
Network Analysis ◽  
Clinical Studies ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

The effects of amantadine on traumatic brain injury outcome: a double-blind, randomized, controlled, clinical trial

Brain Injury ◽  
2018 ◽  
Vol 32 (8) ◽  
pp. 1050-1055 ◽  
Author(s):  
Hossein Ghalaenovi ◽  
Arash Fattahi ◽  
Jalil Koohpayehzadeh ◽  
Mahmoud Khodadost ◽  
Neda Fatahi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled
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