Phase IIIB and Treatment IND Safety Reporting

Abstract

There are important and unique aspects of safety surveillance and reporting for Phase IIIB and treatment investigational new drug (IND) studies. These studies typically involve large numbers of heterogenous patients and thus are likely to result in new safety information. For Phase IIIB studies in the United States, three-day, 10-day, annual, and safety update reporting are required. Treatment INDs may be done with modified safety reporting requirements if the Food and Drug Administration (FDA) grants appropriate waivers. For both types of studies, a real-time, structured process must be maintained to rapidly collect and analyze serious adverse events. Demand for safety updates can arise precipitously and require extraordinary efforts to survey study sites and complete data collection. Studies of rifabutin and nabumetone described in this article exemplify these needs.