What happens after the drug is approved by the FDA for testing in humans?
The sponsor of the IND prepares a plan, or protocol, outlining the institutions and number of people that will take part in the study, the eligibility requirements, the medical tests and interventions they will receive, and how often. The protocol must be approved by NCI (or the organization sponsoring the study) and the Institutional Review Board (IRB) at each hospital or study site. This board, which includes consumers, clergy, and health professionals, reviews the protocol to ensure that the research will not expose patients to extreme or unethical risks. Once the centers and institutions have been selected and protocols approved, phase I and phase II trials are conducted with a limited number of people to determine the safety, dosage, effectiveness, and the side effects of a drug. If these preliminary trials indicate that the drug is well-tolerated and shows some efficacy, phase III trials are initiated. In phase III trials, hundreds of people around the country are assigned at ran
