FAQ - Frequently Asked Questions
What is a clinical
are the phases of a clinical trial?
Phase II - Phase II trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects.
Phase III - Phase III trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine the safety, effectiveness, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling. In Phase III studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to FDA for approval to market the drug. Phase III trials usually involve several hundred to several thousand patients.
Phase IV - Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (Phase IV) studies to delineate additional information about the drug's risks, benefits and optimal use. These studies could include, but would not be limited to, studying different dosages or schedules or administration than were used in Phase II studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.
is an Investigational New Drug?
is the Principal Investigator and how is that person different
from an Investigator?
You should be able to answer the following questions once you have met and discussed a clinical trial with the physician:
*The OPRR 1993 Protecting Human Research Subjects Institutional Review Board Guidelines, pp5-6, 5-7
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