Traumatic brain injury clinical trials
Although Traumatic brain injury is a leading cause of death and disability, none of the clinical trials performed on these patients have shown an overall significant treatment effect. Many authors have published recommendations in order to improve the statistical analysis and design of these trials, such as an adequate prognostic model and the use of ordinal rather than dichotomous outcome analysis 1).
Deep Brain Stimulation for Traumatic Brain Injury-https://clinicaltrials.gov/ct2/show/NCT01277952
Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury- https://clinicaltrials.gov/ct2/show/NCT01287156
1)
Roozenbeek B, Lingsma HF, Perel P, Edwards P, Roberts I, Murray GD, Maas AI,
Steyerberg EW; IMPACT (International Mission on Prognosis and Clinical Trial
Design in Traumatic Brain Injury) Study Group; CRASH (Corticosteroid
Randomisation After Significant Head Injury) Trial Collaborators. The added value
of ordinal analysis in clinical trials: an example in traumatic brain injury.
Crit Care. 2011;15(3):R127. doi: 10.1186/cc10240. Epub 2011 May 17. PubMed PMID:
21586148; PubMed Central PMCID: PMC3218993.