[MOL] Re: Clinical trials [00989] Medicine On Line

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[MOL] Re: Clinical trials

      Dear Pam:  There are three types of clinical trials used to test new
drugs. The first steps taken by a drug company once it has identified a
compound or chemical of interest, which may comes from many different sources,
are laboratory studies to determine whether or not the item under study has
any identifiable effects of interest to that particular company; translation:
will this thing cure or help a disease that has a large enough patient
population for us to make a million from it. Geese...how cynical! Oh, well.
      So, once that has been determined, the next step is animal studies, in
which they examine those effects, see if they hold true and are of significant
interest to warrant pursuing further research. It is often here where side
effects are noted and defined (just the start of that, though).
      Once the drug has passed these examinations, it moves on to human
trials, known as clinicals. These are divided into three phases: Phase I
trials look primarily at dose tolerance levels and side effects. Phase II
trials are where more sophisticated mathematics really kick in to help in the
comparison of the test treatment (by the way, these are not limited to drugs,
but include treatments such as radiation), by comparing one treatment with
another for long term curative or palliative benefits. In Phase III trials the
researchers are tuning up their knowledge of how the drug works.
      Mathematics is a tool used to specify exact measurements (quantities)
and group those in different ways, and compare them with previous or parallel
tests. There are blind tests, in which the patient is not told whether he/she
is receiving the new treatment or a placebo (some harmless compound); there is
also the double-blind test, in which neither the patient or the researcher
knows what a specific patient is being given.
      These procedures are designed to help wipe out any outside influences
which might creep into the test results and influence them, such as personal
belief that a treatment is good or bad. What group of patients a person is put
in is determined by a computer to further reduce those influences.
      There are stringent guidelines written into the grants for these tests
which are designed to protect the patients best interests; on of these states
that a patient will not be given a test treatment if there are better choices
already available for them. There are more to the guidelines, but you get the
idea. The National Cancer Institutes' web site can provide you with more
information on trials, who qualifies and the full guidelines for the
protection of patients. But, as in everything else on this journey, you must
be an informed consumer and an intelligent participant in the decision-making
      So, check it out. Call 1-800-433-0464 and ask for the three free books.
"Fighting Cancer" will help you understand the process. Hope all this helps. I
do get carried away, don't I?

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