The treatment IND is a mechanism for providing eligible subjects with investigational drugs for the treatment of serious and life-threatening illnesses for which there are no satisfactory alternative treatments. A treatment IND may be granted after sufficient data have been collected to show that the drug "may be effective" and does not have unreasonable risks. Because data related to safety and side effects are collected, treatment INDs also serve to expand the body of knowledge about the drug.
There are four requirements that must be met before a treatment IND can be issued:
- the drug is intended to treat a serious or immediately life-threatening disease,
- there is no satisfactory alternative treatment available,
- the drug is already under investigation, or trials have been completed, and
- the trial sponsor is actively pursuing marketing approval.
Treatment IND studies require prospective IRB review and informed consent. A sponsor may apply for a waiver of local IRB review under a treatment IND if it can be shown to be in the best interest of the subjects, and if a satisfactory alternate mechanism for assuring the protection of human subjects is available, e.g., review by a central IRB. Such a waiver does not apply to the informed consent requirement. An IRB may still opt to review a study even if FDA has granted a waiver.
Treatment INDs are discussed under the general heading of expanded access to investigational drugs. FDA issued new regulations that include clinical studies conducted under an IND as well as treatment protocols and treatment INDs.