JCNT

The Deane F. Johnson Center for Neurotherapeutics at UCLA

Leadership in Clinical Trials Research

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Home arrow JCNT Resources arrow For Patients arrow How Are New Treatments Developed?
How Are New Treatments Developed? Print E-mail
  • The first step in developing new therapies begins by understanding the way a neurological disease affects the brain and how we might modify that process.
  • Next, researchers find chemicals that may prevent or control the abnormal process in the brain.
  • Researchers then study the chemicals to see if they are toxic to animals, enter the brain, and have general characteristics that
    suggest they might be used for treatment of the disease.
  • The chemicals must then be tested in normal human volunteers. This step gives information about the safety of the chemicals and if they produce side effects. This is called a Phase I clinical trial.
  • The next step in the process is to give the chemical (now a medication) to patients with the specific neurological disorder to determine the proper dose and to get more information on the safety of the drug. This step is called a Phase II clinical trial.
  • Then the medication or a placebo is given to patients with the disease to compare what happens to the two groups. Usually, half of the patients receive the medication and half receive a placebo. Neither the patient nor the doctor knows who is on the medication and who is on placebo. This is called a Phase III clinical trial. If the medication is better than the placebo, the medication is presented to the Food and Drug Administration (FDA) for approval.
  • If approved by the FDA, the medication becomes available by prescription for treatment of patients with the neurological disorder in which it was tested. The FDA continues to monitor the safety of the approved medication.
 
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