What trials must be registered on ClinicalTrials.gov?

Trials that must be registered under the FDA Amendments Act of 2007 (FDAAA) are called “Applicable Clinical Trials.” These trials generally include:

  • Drug and Biologic Trials:  controlled, clinical investigations*, other than Phase 1 investigations, of a project subject to FDA regulations; and
  • Device Trials: controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance
  • ClinicalTrials.gov accepts registration of all clinical trials: 1) approved by a human subject review board and 2) conforming to the regulations of the appropriate national health authorities.  Both interventional and observational studies are accepted.

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"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

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Exclusions:

The following types of studies are generally excluded (see note) from the registration (and results submission) requirements of FDAAA 801. This is not a complete list.

  • Phase 1 drug trials including studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes (see note)
  • Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes (see note)
  • Trials that do not include drugs, biologics, or devices (such as behavioral interventions)
  • Non-interventional (observational) clinical research, such as cohort or case-control studies
  • Trials that were ongoing as of September 27, 2007, and reached the Completion Date (Primary Completion Date data element on ClinicalTrials.gov) before December 26, 2007 (see note)

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 Note: Trial(s) may be subjected to the Voluntary Submissions provision in FDAAA 801; see the statutory provision for voluntary submission: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=94 

*FDA defines a clinical investigation as any experiment in which a drug 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.  Purely observational studies are exempt from registration requirements.

Further Information:

Elaboration of Definitions of Responsible Party and Applicable Clinical Trial

http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf

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FDAAA 801 Requirements (ClinicalTrials.gov Website)

http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering

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