© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 22, 1668-1670,
November 20, 2002
© 2002 Oxford University Press
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Demand Grows for Early Access to Promising Cancer Drugs
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In recent years, expanded access programs have allowed thousands of patients with cancer to gain access to investigational drugs before they are approved by the U.S. Food and Drug Administration. Prior to the mid-1990s, patients who had exhausted all standard avenues of treatment were able to obtain investigational drugs only on a case-by-case basis.
Expanded access programs are an extension of more traditional compassionate use programs and allow patients to receive investigational drugs earlier than phase III of the clinical trial process. (See sidebar, p. 1669, for descriptions of various ways patients can gain access to investigational drugs.)
Patient advocacy groups have played a key role in the growth of expanded access programs. Over the last decade, the number of advocacy groups for cancer patients has swelled to several hundred, and members of these groups have become increasingly educated about the intricacies of
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