\ ALS Research \ Defining survival as an outcome measure for clinical trials in ALS
Clinical trials in ALS often use patient survival as an outcome measure to examine whether a treatment prolongs life. But variables affecting survival rates – such as emergency tracheostomy – are difficult to control, as patients often require such interventions in late stages of the disease. This prompted Paul Gordon, MD, Associate Medical Director of the ALS Research Center at Columbia University in New York City, and international colleagues to investigate whether tracheostomy should be considered as an alternative to survival as an outcome measure for clinical trials.
The results from the study, published in Archives of Neurology, indicate that despite the frequency of life-extending respiratory interventions during clinical trials in ALS, survival is the most reliable outcome measure. The authors cite differences in the use of respiratory interventions between trial centers and the timing of such interventions in the disease process as sources of variability for tracheostomy as an outcome measure.
|
|
Click Here For A Printer Friendly Version Of This Page
Defining survival as an outcome measure for clinical trials in ALS
By: Katie MoisseClinical trials in ALS often use patient survival as an outcome measure to examine whether a treatment prolongs life. But variables affecting survival rates – such as emergency tracheostomy – are difficult to control, as patients often require such interventions in late stages of the disease. This prompted Paul Gordon, MD, Associate Medical Director of the ALS Research Center at Columbia University in New York City, and international colleagues to investigate whether tracheostomy should be considered as an alternative to survival as an outcome measure for clinical trials.
The results from the study, published in Archives of Neurology, indicate that despite the frequency of life-extending respiratory interventions during clinical trials in ALS, survival is the most reliable outcome measure. The authors cite differences in the use of respiratory interventions between trial centers and the timing of such interventions in the disease process as sources of variability for tracheostomy as an outcome measure.
| Posted On: Wednesday, January 13, 2010 Modified: Wednesday, January 13, 2010 Category: ALS Research Posted By: |