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What are Clinical Trials?
Clinical trials are scientific studies whose goal is to obtain information
about different methods of treating cancer. There have been great strides
made in survival, quality of life and treatment of cancer patients as
a direct result of clinical trials. The willingness of the patients (and
their families) to participate in this valuable research is how we answer
the question of which treatment is best.
How are clinical trials regulated?
Our physicians are members of national research groups regulated by the Food
and Drug Administration, the National Institute of Health and the National Cancer
Institute. There is a review board in Yakima called the Institute Review Board
comprised of local medical personnel from other hospitals and lay people from
the community who oversee all the research studies open to the patients at North
Star Lodge. We have clinical trials staff whose sole purpose is to search out
and maintain trails that will benefit our patients.
What kinds of trials are available?
There are trials open for just about every type of cancer but criteria for
participation is very selective.
Phase I and II Trials - test for dose and effectiveness.
Phase III Trials - The majority of the trials at North Star Lodge are Phase
III trials. These trials compare the current treatment for a type of cancer
against a new treatment that has shown merit in a Phase I or II trial.
How are patients selected for clinical trials?
Two Ways of Selection:
1. Clinical trials staff prescreens the records of referred patients for eligibility
and then informs the physician that the patient might be eligible for entrance
into a study.
2. The physician after consulting with the patient and reviewing the chart
contacts the clinical trials staff about a trial that might benefit a patient.
What happens after a patient qualifies for a clinical trial?
1. The physician or a member of the clinical trials staff presents the patient
and their family with the idea of a clinical trial and information on clinical
trials in general and consent form. The patient is encouraged to take the information
home to read and discuss at their leisure.
2. If the patient wants to participate they sign form at the clinic and are
then registered in the clinical trial.
What occurs during the clinical trials?
Each trial is different, however, for all of the trials during the active phase
of treatment the patients are carefully monitored for reactions and quality
of life.
What occurs after the clinical trial?
The follow-up phase is different for every study but routinely follows the
normal schedule of recommended physicians visits and tests.
Clinical trials are completely voluntary. The patient
has the right to withdraw from the study at any time during treatment or follow-up.
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