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Group C (Treatment IND) Drugs

BayBiotech.NET

Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information.

Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy.

Making Group C drugs available to the critically ill patients not only provides them when they need it the most but also allows NCI to gather information about safety and activity of the drug prior to the final FDA approval.

For active investigational agents not meeting the criteria for Group C, the NCI may still provide drugs on a compassionate basis to requesting physicians for patients whose best medical interests require them. These decisions are made on a case-by-case basis, often after discussion between the requesting physician and the NCI staff.

To find out more about Group C drugs click here.

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