FDA to Hold Clinical Trials Training Course

The FDA will conduct a three-day training course for clinical investigators, beginning Nov. 8. The course, which will be held at the National Labor College in Silver Spring, Md., is part of the Clinical Trials Transformation Initiative. The course will cover fundamental issues in the design and conduct of trials, statistical and analytic considerations in interpreting trial data, appropriate safety evaluation, ethical considerations and regulatory requirements, compliance issues, and essential toxicological and manufacturing data to support human investigational use.