Sep 12, 2012
The U.S. FDA issued a statement in July 2012 reminding investigators of legal requirements to list certain clinical trials and report results on the government’s ClinicalTrials.gov database. ASCO encourages all clinical investigators to familiarize themselves with the reporting requirements.
According to the FDA Amendments Act of 2007, “applicable clinical trials” may be subject to mandatory registration and results reporting. Applicable trials generally include controlled interventional studies of drugs, biologic products, or devices subject to FDA regulation. These products are subject to regulation when they are evaluated in a clinical trial at one or more U.S. sites, are manufactured in the United States or its territories and exported for study in another country, or are studied under an investigational new drug application (IND) or investigational device exemption (IDE). IND-exempt trials may also be subject to reporting regulations.
“Applicable device clinical trials” are prospective study of health outcomes comparing a device-based intervention subject to FDA regulation against a control in human subjects (not a small clinical trial to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility, not health outcomes) or pediatric post-market surveillance trials. “Applicable drug clinical trials” are controlled clinical investigations, other than a phase I clinical investigation, of a drug (including biological products) subject to FDA regulation. In these regulations, the 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.”
For applicable clinical trials of drugs, biological products, and devices that were initiated after September 27, 2007 (or were ongoing 90 days after that date), and are trials of approved products, results are generally due 12 months after the completion date of the clinical trial. The completion date is defined as the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. Currently, results are not required to be submitted for applicable clinical trials of unapproved products.
Investigators can find resources for understanding the requirements for registering trials and reporting results at prsinfo.clinicaltrials.gov.
According to the FDA Amendments Act of 2007, “applicable clinical trials” may be subject to mandatory registration and results reporting. Applicable trials generally include controlled interventional studies of drugs, biologic products, or devices subject to FDA regulation. These products are subject to regulation when they are evaluated in a clinical trial at one or more U.S. sites, are manufactured in the United States or its territories and exported for study in another country, or are studied under an investigational new drug application (IND) or investigational device exemption (IDE). IND-exempt trials may also be subject to reporting regulations.
“Applicable device clinical trials” are prospective study of health outcomes comparing a device-based intervention subject to FDA regulation against a control in human subjects (not a small clinical trial to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility, not health outcomes) or pediatric post-market surveillance trials. “Applicable drug clinical trials” are controlled clinical investigations, other than a phase I clinical investigation, of a drug (including biological products) subject to FDA regulation. In these regulations, the 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.”
For applicable clinical trials of drugs, biological products, and devices that were initiated after September 27, 2007 (or were ongoing 90 days after that date), and are trials of approved products, results are generally due 12 months after the completion date of the clinical trial. The completion date is defined as the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. Currently, results are not required to be submitted for applicable clinical trials of unapproved products.
Investigators can find resources for understanding the requirements for registering trials and reporting results at prsinfo.clinicaltrials.gov.