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Common Terms to Understand When Considering a Clinical Trial

Making the Process Faster

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One of the objectives of the FDA is to make drugs available in a shorter amount of time, while still focusing on the protection and safety of study participants. These measures include:

Drug Categorization: In order to speed the drug review process, the FDA now categorizes drugs as:

  1. Standard Drugs: Drugs which provide only minimal or no improvement over drugs already available on the market.
  2. Priority Drugs: Drugs which may provide a major advancement in treatment. Priority drugs include drugs that are already in existence, but where treatment improvement may be made by providing a new dosage form or a new use of the drug.

Treatment Investigational New Drugs (IND): Treatment IND's fall under the FDA's "expanded access" program. The purpose of these various expanded access programs is to provide availability of a drug to a greater number of people, as early as possible during the clinical trial process. The drugs are administered to those patients who are not eligible to be in the definitive clinical trials, which are typically in Phase III studies.

In order for a drug to qualify for the expanded access program, it must have already shown promise in its effectiveness, and the intended use must be treatment of a serious or life-threatening condition. The drugs may also be administered when there is no comparable alternative drug or therapy available to treat a specific stage of a life-threatening disease.

Probably the most well known use of a Treatment IND, is AZT, an anti-viral medication used to treat people with HIV/AIDS. During the AZT Phase II trial, which included about 300 participants, it was noted that 19 patients receiving a placebo had died. Only 1 death was recorded for those participants receiving AZT. Within one week, placebo the FDA authorized a new treatment protocol for AZT. As a result, 4,000 people were treated with the drug before its approval.

To date the FDA has approved more than 40 drugs for the Treatment IND program. These drugs have been primarily used in the treatment of HIV/AIDS and cancer.

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