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Clinical Trials

Research Process

Research studies are designed to evaluate the safety and efficacy of medications or medical devices by monitoring their effects on large groups.

Clinical Research

Clinical research studies are designed to evaluate the safety and effectiveness of medications or medical devices by monitoring their effects on large groups.

Patient-oriented research is conducted to discover what causes human disease and how it can be prevented and treated. Researchers investigate mechanisms of human disease, therapeutic interventions, and new technologies. Epidemiologic and behavioral studies, and outcomes research, and health services research can also be part of clinical research.

The Department of Psychiatry and Behavioral Neurosciences is currently conducting clinical research for the following types of disorders:

Clinical research involves a process that consists of the following steps:

1. Discovery - The creation of a new medicine begins.

2. Preclinical Development - Clinical research studies are designed to evaluate the safety and effectiveness of medications or medical devices by monitoring their effects on large groups.

3. Human Clinical Trials - Phase I, II, III and IV studies

  • Phase I: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, monitor the side effects associated with increasing doses, and gain early evidence of efficacy and safety. Phase I studies may include healthy participants and/or patients.
  • Phase II: Controlled clinical studies conducted to evaluate the efficacy of the drug for a particular indication(s) in patients with the disease or condition under study. Phase II studies also determine the common short-term side effects and risks.researchers focus on to determine the most effective dosages for the new medicine.
  • Phase III: Expanded controlled and uncontrolled trials to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling. If Phase III trials are successful, the drug can be registered and approved:
    Registration: The filing of a New Drug Application (NDA) with the U.S. FDA or a Market Authorization Application with the European Agency for the Evaluation of Medicinal Products (EMEA).
    Approvals: New medicines that are approved for marketing to the general population in the U.S or Europe.
  • Phase IV: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.