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Clinical Trials:
The future of mesothelioma treatment

Dana Nolan
Mental Health Counselor
Understanding clinical trials
•
•
•
•
•

Goals of clinical trials
Phases of trials
Eligibility
How do I find clinical trials?
Questions, choices and decisions

(800) 615-2270
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.
(800) 615-2270
Types of trials in cancer care





Treatment
Prevention
Diagnostic/screening
Palliative care/symptom control

(800) 615-2270
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)

(800) 615-2270
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)
(800) 615-2270
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

(800) 615-2270
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.
(800) 615-2270
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.
(800) 615-2270
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!
(800) 615-2270
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
Contact Information

1-800-615-2270

(800) 615-2270

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The Mesothelioma Center's January Support Group: Are Clinical Trials Right For Me?

  • 1. Clinical Trials: The future of mesothelioma treatment Dana Nolan Mental Health Counselor
  • 2. Understanding clinical trials • • • • • Goals of clinical trials Phases of trials Eligibility How do I find clinical trials? Questions, choices and decisions (800) 615-2270
  • 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. (800) 615-2270
  • 4. Types of trials in cancer care     Treatment Prevention Diagnostic/screening Palliative care/symptom control (800) 615-2270
  • 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) (800) 615-2270
  • 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) (800) 615-2270
  • 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 (800) 615-2270
  • 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. (800) 615-2270
  • 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. (800) 615-2270
  • 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! (800) 615-2270
  • 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