FDA Requirements for Registration

Registration of studies with ClinicalTrials.gov

Clinical trials that evaluate the efficacy of drugs for serious or life-threatening diseases, and conducted under an Investigational New Drug application are mandated under the The Food and Drug Modernization Act of 1997 (FDAMA) to be registered to a central data bank.

In addition, the ICMJE is expanding the definition of the types of trials that must be registered to include preliminary trials, and adopts the World Health Organization's definition of a clinical trial which includes any intervention used to modify a biomedical or health-related outcome (examples include drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in subjects, including pharmacokinetic measures and adverse events. Observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not be required to register. The ICMJE member journals will implement the expanded definition for all trials that begin enrollment on or after July 1, 2008.

Clinicaltrials.gov provides information about a trial's purpose, eligibility, locations where studies are being conducted, and contact information. All federally funded trials should be posted. Failure to register studies prior to starting the study can seriously jeopardize the ability to publish or otherwise utilize the data due to policies of the International Association of Journal Editors.



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