Treatment IND

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 the desperately ill patients as early in the drug development process as possible. The U.S. Food and Drug Administration (FDA) permits investigational drugs to be used under a treatment IND, if there is preliminary evidence of drug efficacy and the drug is only intended to treat a serious or life-threatening disease in their later stage of development.Few examples include such as HIV/AIDS, herpes simplex encephalitis and subarachnoid hemorrhage ,or it may be used if there is no alternative drug or therapy available to treat that degree in an 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. Also in which premature death is likely without early treatment. Treatment INDs are made available to patients in need 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.^[1] Treatment INDs are rare; for the period of 1987-1999, only 39 such applications were approved.^[2] Of these 39 experimental treatments, 13 were allowed for cancer and 11 for HIV/AIDS.^[2] Patient advocates and healthcare activists often push for companies to apply for Treatment INDs, in hope of a new drug that may hold some promise to cure or treat a disease.^[2] 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.^[2]

References

• http://irb.mc.duke.edu/InvestigationalProducts.htm

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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.