From: "Dr. D. Kossove" <doctordee@telkomsa.net>
Subject:  Re: Compassionate Use
Date: Wednesday, December 03, 2003 10:53 PM

Date:    Wed, 3 Dec 2003 17:14:10 -0500
From:    Marcia Koch <marciakoch@TECHFENCE.COM>
Subject: Re: Compassionate Use

I did look further - from the NCI's website:

Special Exception/Compassionate Exemption
 Patients who do not meet the eligibility criteria for a clinical trial =
of an investigational drug may be eligible to receive the drug under a =
mechanism known as a special exception or a compassionate exemption to =
the policy of administering investigational drugs only in a clinical =
trial. The patient's doctor contacts the sponsor of the investigational =
agent and provides the patient's medical information and treatment =
history; requests are evaluated on a case-by-case basis. The FDA must =
approve each request to provide the drug outside a clinical trial. There =
should be reasonable expectation that the drug will prolong survival or =
improve quality of life.=20
These are some questions that are considered when determining if a =
patient may be a candidate to receive an investigational drug as a =
special exception:

  a.. Is the patient ineligible for a clinical trial?=20
  b.. Have standard therapies been exhausted?=20
  c.. Is there objective evidence that the investigational agent is =
active in the disease for which the request is being made?=20
  d.. Can the drug potentially benefit the patient?=20
  e.. What is the risk to the patient?=20
In some cases, even patients who qualify for treatment with an =
investigational drug on a "compassionate basis" might not be able to =
obtain it if the drug is in limited quantity and high demand.

http://cis.nci.nih.gov/fact/7_46.htm

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