Treatment IND
Encyclopedia
Treatment IND or treatment investigational new drugs, is a United States regulation (made by the federal register
, May 22, 1987) used to make promising new drugs available to desperately ill patients as early in the drug development process as possible. The U.S. Food and Drug Administration
(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 in their later stage of development such as HIV
/AIDS
, herpes simplex encephalitis and subarachnoid hemorrhage
or if there is no alternative drug or therapy available to treat that stage of the disease in the intended individuals. 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. 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. Treatment INDs are rare. For the period of 1987-1999, only 39 such applications were approved. Of these 39 experimental treatments, 13 were for cancer and 11 were for HIV/AIDS. Patient advocates and healthcare activists often push for companies to apply for Treatment INDs when they think a new drug may hold some promise to cure or treat a disease. There are many problems associated with this, however. Some examples include drug companies preferring controlled clinical trials over treatment INDs and patient costs, since insurance companies don't cover experimental treatments.
Federal Register
The Federal Register , abbreviated FR, or sometimes Fed. Reg.) is the official journal of the federal government of the United States that contains most routine publications and public notices of government agencies...
, May 22, 1987) used to make promising new drugs available to desperately ill patients as early in the drug development process as possible. The U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(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 in their later stage of development such as HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
/AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
, herpes simplex encephalitis and subarachnoid hemorrhage
Subarachnoid hemorrhage
A subarachnoid hemorrhage , or subarachnoid haemorrhage in British English, is bleeding into the subarachnoid space—the area between the arachnoid membrane and the pia mater surrounding the brain...
or if there is no alternative drug or therapy available to treat that stage of the disease in the intended individuals. 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. 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. Treatment INDs are rare. For the period of 1987-1999, only 39 such applications were approved. Of these 39 experimental treatments, 13 were for cancer and 11 were for HIV/AIDS. Patient advocates and healthcare activists often push for companies to apply for Treatment INDs when they think a new drug may hold some promise to cure or treat a disease. There are many problems associated with this, however. Some examples include drug companies preferring controlled clinical trials over treatment INDs and patient costs, since insurance companies don't cover experimental treatments.
External links
- Preapproval Opportunities. Applied Clinical Trials, June 2008.
- Boundaries of Expanded Access. Pharmaceutical Executive, May 2008.
- A Time for Compassion. Applied Clinical Trials, September 2007.
- Expanded Access to Investigational DrugsGenetic Engineering & Biotechnology News, January 15, 2010.