scientific Sessions

Clinical trials are research studies in pharmaceutical research and development that evaluate the safety and efficacy of new medical interventions, including treatments such as vaccines, medicines, dietary supplements, etc.; procedures such as transplantation; and tools such as pacemakers. Clinical trials are major steps in pharmaceutical research and development, taking 6 to 7 years to complete.

At the beginning of clinical trials, investigators recruit a small number of volunteers and then involve a larger pool to conduct studies to examine the safety and efficiencies of drugs. Clinical trials have five phases: phase 0, phase I, phase II, phase II, and phase IV. The U.S. Food and Drug Administration (FDA) monitors and approves the trial results. Each phase of the clinical trial has a specific purpose. For example, phase 0 checks for pharmacodynamic and pharmacokinetics properties in humans; phase I screens the drug for safety; phase II assesses dosing requirements; phase III confirms drug efficiency and effectiveness; and phase IV assesses the safety of the drug post-marketing. The U.S. Food and Drug Administration (FDA) approves the drug for marketing once it completes Phase III