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.
"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
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)
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.
Elaboration of Definitions of Responsible Party and Applicable Clinical Trial
FDAAA 801 Requirements (ClinicalTrials.gov Website)http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering
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