Yes, any applicable clinical trial, including applicable clinical trials conducted outside the
United States, must comply with the new regulation (21 CFR § 50.25(c)) and include the
statement regarding www.ClinicalTrials.gov in informed consent forms. The statute
defines applicable clinical trials as trials of drugs and devices that are subject to FDA
regulation. If the clinical trial is not of a drug or device subject to FDA regulation, and,
thus, not an applicable clinical trial, at the time of the initiation of the trial, then the
statement is not required. See the response to questions 3 and 4 concerning the definition
of an applicable clinical trial.
FDA accepts data from foreign clinical trials not under an IND when in compliance with
21 CFR § 312.120. The mere fact that we accept data from a foreign clinical trial in
connection with a marketing application does not make it an applicable clinical trial; the
foreign clinical trial constitutes an applicable clinical trial only when it meets the
definitions set forth in 42 U.S.C. § 282(j)(1)(A). See, also, the response to questions 3
and 4.
This requirement does not preclude the inclusion of mandatory or recommended
language from non-U.S. governments, and it does not preclude reference to other clinical
trial registries or regulatory bodies.