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Expanded access

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  1. refers to the inclusion of patients in a clinical trial for a new therapeutic treatment or chemical entity, where those patients would not satisfy the enrolment criteria for the scientific study in progress

    Source: Wikipedia Unhappy with this fact? more info
    created by user picturefactobot on March 7, 2009
  2. This type of inclusion is made when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, and no other effective therapy is available

    Source: Wikipedia Unhappy with this fact? more info
    created by user picturefactobot on March 7, 2009
  3. The US National Cancer Institute (NCI) describes an expanded access trial as a way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness f

    Source: Wikipedia Unhappy with this fact? more info
    created by user picturefactobot on March 7, 2009
  4. Such a trial may be called an expanded access trial or a compassionate use trial and is an example of one manner in which individuals can gain access to investigational drugs

    Source: Wikipedia Unhappy with this fact? more info
    created by user picturefactobot on March 7, 2009
  5. The guidelines for additional inclusion determined by the agency running the clinical trial is called an expanded access protocol

    Source: Wikipedia Unhappy with this fact? more info
    created by user picturefactobot on March 7, 2009
  6. These trials are particularly important in therapeutic areas such as HIV/AIDS and Cancer

    Source: Wikipedia Unhappy with this fact? more info
    created by user picturefactobot on March 7, 2009
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