Post on 28-Jan-2015
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Clinical Trials:The future of mesothelioma
treatment
Dana NolanMental Health Counselor
Understanding clinical trials
• Goals of clinical trials• Phases of trials• Eligibility• How do I find clinical trials?• Questions, choices and decisions
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Why do medical researchers engage in clinical trials?
o Pharmaceutical drugso Surgical procedureso Medical equipmento Treatment protocols
• Clinical trials are different from other types of drug or equipment trials in that they involve people.
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Types of trials in cancer care
Treatment Prevention Diagnostic/screening Palliative care/symptom control
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Phases of clinical trials
Phase 0 (very small number of subjects, micro-dosing, 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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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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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/treatment-trial-guide/detailschecklist
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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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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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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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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.
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Contact Information
1-800-615-2270
(800) 615-2270