The first step is to examine the inclusion criteria....
[T]he next step is to phone...the investigator....
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Inclusion and Exclusion Criteria
The following excerpt is taken from Chapter 7 of Cancer Clinical
Trials: Experimental Treatments & How They Can Help You by Robert
Finn, copyright 1999 by O'Reilly & Associates, Inc. For book
orders/information, call (800) 998-9938. Permission is granted to
print and distribute this excerpt for noncommercial use as long as the
above source is included. The information in this article is meant to
educate and should not be used as an alternative for professional
medical care.
The first step is to examine the inclusion criteria, the list of conditions you
must meet in order to be considered for participation in a certain clinical
trial. It's easy to find the list inclusion criteria, since they're featured
prominently in every clinical trial listing, even those that are very brief.
You'll learn very quickly, for example, that a certain clinical trial is looking
for people with Stage III or Stage IV non-small-cell lung cancer. If you have
Stage II lung cancer, or small-cell lung cancer, or a different kind of cancer
entirely, it's pointless even to make a phone call to investigate the trial
further, no matter how promising you believe the treatment to be. You simply
won't be considered if you don't meet the inclusion criteria.
If you seem to meet the inclusion criteria, the next step is to phone (or to
have a friend, relative, or your physician phone) the investigator or the
clinical trial coordinator. The first thing she'll do will be to ask you about
your diagnosis. She may have a more detailed list of inclusion criteria than
those that were in the brief clinical trial description. If you still seem
eligible, she'll go over the exclusion criteria.
This is where most potential participants in the clinical trial fall out. In
many trials more than 90 percent of people inquiring about a clinical trial are
excluded. Dr. David Jablons, a thoracic surgeon and cancer expert at the
University of California, San Francisco explains:
The typical clinical trial in cancer is not being done in early
stage patients who have the luxury, hopefully, of a long disease-free interval.
On the contrary, it's being done on patients with advanced disease who are
desperate for any potential, hopeful, experimental therapy. The problem is that
the studies usually (but not always) are looking at patients that are freshly
diagnosed with advanced disease who haven't seen a lot of therapy to date. It
helps keep the data cleaner. If you have a Substance X that you think is really
going to be effective, and you start it on patients who have never seen any
chemotherapy, who have never had any radiation, then it's pretty easy to say
that the result is due to the trial drug. On the other hand, if they've had a
bunch of chemotherapy and then you give them Substance X, the data are not as
clean.
It's really a paradox. The patients who are the most desperate, the most
motivated, and the most interested in innovative therapy plans are usually the
patients who have failed conventional therapy.
Some critics of the current system of clinical trials cite overly strict
exclusion criteria as the primary cause of the low levels of patient
participation.1 Moreover, they charge that the reasoning behind the desire for
strict exclusion criteria may be faulty. The designers of clinical trials want a
homogeneous population that has the best possible chance of responding to the
experimental treatment. If they succeed in finding that population, clinical
trials would take less time and would be less expensive. But that assumes that
trial designers can tell in advance which subgroup of patients with a given
disease would respond better. There's no evidence that that's the case, and
suppose they guess wrong? There's a possibility that they're excluding the very
patients who may benefit the most from the new treatment. As Dr. Jablons notes,
Sometimes the rules can be bent. For example, if they've had
radiation a year ago, focal radiation might not rule a patient out. But if a
person has failed fourteen different drugs as of a month ago, and their disease
is rapidly progressing, is that the right person to try a new substance on? It
could be, because if you saw a response, you'd say that not only is Substance X
effective, but it's effective as a salvage treatment. The problem is that these
are rapidly progressing diseases. Clinical disease doesn't always wait for
careful, controlled, cautious, trial progression.
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