Treatment IND
Treatment Investigational New Drugs (Federal
Register, May 22, 1987) are used to make promising
new drugs available to desperately ill patients as early in the
drug development process as possible. FDA will permit an
investigational drug to be used under a treatment IND if there is
preliminary evidence of drug efficacy and the drug is intended to
treat a serious or life-threatening disease, or if there is no
comparable alternative drug or therapy available to treat that
stage of the disease in the intended patient population. In
addition, these patients are not eligible to be in the definitive
clinical trials, which must be well underway, if not almost
finished.
An immediately life-threatening disease means a stage of a
disease in which there is a reasonable likelihood that death will
occur within a matter of months or in which premature death is
likely without early treatment. For example, advanced cases of
AIDS, herpes simplex encephalitis, and subarachnoid hemorrhage
are all considered to be immediately life-threatening diseases.
Treatment INDs are made available to patients before general
marketing begins, typically during Phase 3 studies. Treatment
INDs also allow FDA to obtain additional data on the drug's
safety and effectiveness.