FDAAA provided a definition of “applicable clinical trial” in 42 U.S.C. § 282(j)(1)(A).
“Applicable clinical trials” generally include controlled interventional studies (with one
or more arms) of drugs, biological products, or devices that are subject to FDA
regulation, meaning that the trial has one or more sites in the United States, involves a
drug, biologic, or device that is manufactured in the United States (or its territories), or is
conducted under an investigational new drug application (IND) or investigational device
exemption (IDE). Trial sponsors and investigators have the responsibility of determining
whether or not a trial is an “applicable clinical trial.” Definitions vary for applicable
device and drug trials including biologics.
The trial is an “applicable clinical device trial” if: (I) the trial prospectively compares a
device-based intervention subject to FDA regulation against a control in human subjects;
or (II) the trial is a pediatric post-market surveillance trial. 42 U.S.C. § 282(j)(1)(A)(ii).
The trial is an “applicable clinical drug trial” if the trial is a controlled clinical
investigation, other than a phase I clinical investigation, of a drug subject to FDA
regulation. 42 U.S.C. § 282(j)(1)(A)(iii)(I). For the purposes of this definition, a
“clinical investigation” is “any experiment in which a drug is administered or dispensed
to, or used involving, one or more human subjects.” 21 CFR § 312.3.
