Expanding the registration information in ClinicalTrials.gov improves people's ability to find clinical trials in which they may be able to participate and access investigational therapies. More information about the scientific results of trials, whether positive or negative, may help inform health-care providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study, and improve study designs, ultimately advancing the development of clinical interventions.
Requirements under the final rule apply to most interventional studies of drug, biologic, and device products that are regulated by the FDA. The requirements do not apply to phase I trials of drug and biologic products or small feasibility studies of device products. The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted or what data must be collected.