Abstract
Investigational drugs are regulated by the Food and Drug Administration (FDA) and are not available for widespread patient use. They are screened and evaluated extensively before they are administered to humans in clinical trials. The clinical development process is divided into three phases: phase I, II, and III. Protocols for the investigational agent in each of these phases must be approved by an institutional review board and the patient must be informed of the risks of the study and sign an informed consent document. Once adequate clinical data are collected and analyzed, the information is submitted to the FDA for their review and approval for marketing. Prior to that approval, the FDA may approve broader distribution of the drug for specific indications under a Treatment Investigational New Drug (IND) or the National Cancer Institute's (NCI) group C mechanism. Pharmacists can play a unique role during development of the Treatment IND by contributing to design of the protocol and screening patient qualifications. The investigator of the clinical trial has responsibility for the conduct of the clinical trial and must comply with FDA regulations and sponsor policies.
This is a US government work. There are no restrictions on its use.
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