Research for new central nervous system (CNS) diseases is increasing and gaining interest, but the trials are in general complicated. One of the challenges is that there is a lot of “noise” from placebo arms from specific study end-points. Since many CNS diseases behavior cannot be monitored by biomarkers, such as in the case of cancer, it is difficult to have objective end-points. Instead, the CNS diseases trials rely on subjective end-points, such as scales and questionnaires completed by physicians, patients, and caregivers. This contributes to the “noise” in placebo arms and maybe compromise study results.
Check out the note below from PharmaVoice “CNS Research Challenges” by Denise Myshko for more information about the difficulties in CNS research and what CROs and sponsors are doing to have better and more reliable results in the trials.
It is very important to select qualified investigators to perform these kinds of trials. At Althian, we have experienced investigators specialized in neurology. We have performed several CNS diseases trials, for example, epilepsy, multiple sclerosis and amyotrophic lateral sclerosis.
PharmaVoice article: http://www.pharmavoice.com/article/2016-06-cns-research/