What trials have to be registered in ClinicalTrials.gov?
The applicable clinical trials include the following categories: Devices: Any prospective clinical study of health outcomes comparing an intervention with a device requiring FDA clearance, approval, or exemption against a control in human subjects, except small clinical studies of feasibility. Pediatric post-approval surveillance studies of devices required by FDA. Drug and Biological Products: Any controlled clinical investigation, except for Phase I trials, of a drug or biological product regulated by FDA, where clinical investigation means any experiment in which a drug (or biological) is administered or dispensed to, or used, involving one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Generally, the following types of controls are recognized in clinical investigations: 1) placebo concurrent control; 2) dose comparison concurrent control; 3) no treatment concurrent control; 4) active treatment conc
