Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Description

Study Type— Use this field to limit your search to one of the following clinical study types:
  • Interventional Study (or Clinical Trial)— A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
  • Observational Study— A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).
    • Patient Registry— A type of Observational Study that collects uniform data prospectively for a population defined by a particular disorder/disease, condition, or exposure and that serves a predetermined scientific, clinical, or policy purpose.
  • Expanded Access— A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial.

    For more information on expanded access programs, please visit the FDA Web site at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm.