Health outcome studies must be registered in clinicaltrials.gov
This requirement applies to:
- All NIH-funded trials such as phase 1 studies or clinical trials of behavioral interventions or non-FDA-regulated products.
- Clinical trials involving FDA-regulated drug, biologic and device products
- Any study intended for publication in a journal recognized by the ICMJE
Behavioral interventions are sometimes clinical trials
The Dept of Health and Human Services defines clinical trials as:
“…any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions1 to evaluate the effects on health outcomes2.”
1Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes).
2Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”
FDA regulated studies are clinical trials
The FDA / NIH and Centers for Medicare/Medicaid (CMS) require study registration for all “applicable clinical trials”.
Applicable Clinical Trials generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:
- The trial has one or more sites in the United States
- The trial is conducted under an FDA investigational new drug application or investigational device exemption
- The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research
How to register your USC study to clinicatrials.gov:
NIH Definition of Clinical Trial Decision Tree
HHS requirement for study registration[page not found]
Journal requirement for study registration
Recommendation for study registration (USC Vice President of Research)