When you have a rare cancer like mesothelioma, it can be challenging to find treatment options as well as hope for your future. Clinical trials offer patients the opportunity to try the latest medications, surgical procedures or diagnostic screening tools which do provide realistic hope for longer, better quality of life. Many patients have questions about how to find clinical trials that they may be eligible for, understanding the different phases of a clinical trial and what to expect throughout the process. During our January session, we will discuss this and more!
3. Why do medical researchers
engage in clinical trials?
o
o
o
o
Pharmaceutical drugs
Surgical procedures
Medical equipment
Treatment protocols
• Clinical trials are different from other types of
drug or equipment trials in that they involve
people.
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4. Types of trials in cancer care
Treatment
Prevention
Diagnostic/screening
Palliative care/symptom control
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5. Phases of clinical trials
Phase 0 (very small number of subjects, microdosing, few treatment options left)
Phase 1 (small number of subjects, determines
maximum dose, monitor side effects)
Phase 2 (up to a few hundred subjects, further
investigates dosing and safety of drug/treatment, if
promise is shown then progress to Phase 3)
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6. Phases (con’t)
Phase 3 (up to several thousand
subjects, randomized to control
group or experimental group,
control group DOES NOT get
placebo but the current standard
of care)
Phase 4 (usually takes place after
FDA has approved the treatment,
usually sponsored by drug
companies)
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7. Eligibility criteria
Each clinical trial has strict eligibility criteria to
ensure the integrity of the study and get the most
accurate study results.
If you are looking for a clinical trial yourself,
complete the Cancer Details Checklist to determine
your potential eligibility for a trial:
http://www.cancer.gov/clinicaltrials/search/treatmenttrial-guide/detailschecklist
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8. How do I find clinical trials?
• National Cancer Institute funds and
regulates MANY of the ongoing clinical
trials.
• Most other clinical trials list their
information on the NCI clinical trials
website, so search their site first:
http://www.cancer.gov/clinicaltrials/search
• Enter your information from the Cancer
Details Checklist to see if there are any
trials open to you.
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9. Questions
What should I ask about participating in a clinical trial?
• What are the benefits of this trial?
• What are the risks?
• Can I stop the trial once I start?
• Who pays for my care?
The clinical trial informed consent is a document that
outlines all of the above, however these consents can
be VERY lengthy and sometimes hard to understand,
so ask your provider or clinical trials nurse your
questions.
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10. Choices and Decisions
Choices are great (standard
treatment vs. a potentially
promising new treatment)
Stress of making the wrong choice
Pressure from our loved ones to
make one choice over the other
Careful consideration to
determine what YOU, the patient,
really wants to do!
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11. Clinical trials conclusions
All of our current cancer treatments
started with clinical trials.
There are always new clinical trials in the
works so search regularly.
Ask your oncologist OR do your own
research and see if you are eligible for a
clinical trial.
Ask a LOT of questions so that you feel
good about whatever decision you make in
your treatment.
(800) 615-2270