Controlled clinical trials are now necessary for the approval of new therapies. Besides academic centers and large pharmaceutical companies, individual practicing physicians may also be involved in clinical trials.
Mat Med has worked in a number of different indications in the neurosciences area, including Major Depressive Disorder, Attention-Deficit-Hyperactivity-Disorder, Alzheimer’s Disease, Parkinson’s Disease, Huntingdon Disease, Schizophrenia, Pain (acute pain, arthritic pain, diabetic peripheral neuropathic pain, post-herpetic neuralgia, fibromyalgia), restless legs syndrome, and migraine. Challenges in the neurosciences area include high placebo response in some indications, monitoring of suicidal ideation and behavior, assessment of symptoms that emerge on discontinuation of treatment, and carrying out studies in subjects with significant cognitive impairment.
• Clinical trials are essential for new drug development as evidence of efficacy and safety is required for approval by regulatory authorities.
• Biomarkers and pharmacogenomics are playing an important role in the design and monitoring of clinical trials.
• Basic methods of clinical trials are applicable in neurology, but there may be specific problems associated with clinical trials of disorders such as multiple sclerosis.