Navigating the Clinical Trials Pathway By Toni Kay Mangskau

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Navigating the Clinical Trials PathwayBy
Toni Kay Mangskau Judith Kaur, M.D. Mayo
Clinic Cancer Center
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What are Clinical Research Studies?

• A process to find new and better ways to
  understand, detect, control and treat illness
• A way to find answers to difficult scientific or
  health questions

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Types of Research Studies

• Prevention
• Screening
• Diagnostic
• Treatment
• Genetic (may be a part of all the above)
• Symptom Management/Quality of Life

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Participant Volunteers

• Healthy people
• People at high risk for disease or illness
• People diagnosed with disease or illness

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Research Terms

• Clinical Studies
• Research Studies
• Research
• Experiments
• Clinical Trials more specific term

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What is a Clinical Trial?

• A study that involves a drug or medical device to
  see if it provides safe and effective treatment
• Not all research is considered a clinical trial

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Phase 1 Clinical Trial

• 20-80 participants
• Determine safe dosage
• Select how treatment is given

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Phase 2 Clinical Trial

• 100 300 participants
• Evaluate effectiveness
• Monitor side effects

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Phase 3 Clinical Trial

• 1000 - 3000 participants
• Compare new treatment to standard treatment
• FDA approval after Phase 3
• Some studies stop here

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Phase 4 Clinical Trial

• 20 1000 participants
• Monitoring of FDA Approved drugs or devices
• Look for additional side-effects

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Who Sponsors Clinical Research?

• National Institutes of Health
• Pharmaceutical Companies
• Foundations/Organizations

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Why Mayo Does Clinical Research

• Our commitment to research is based on our
  knowledge that medicine must be constantly moving
  forward, that we need to continue our efforts to
  better understand disease and bring the latest
  medical knowledge to our practice and to our
  patients
• Hugh Smith, M.D. Former Chair of Mayo
  Clinic Board of Governors

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Mayo Clinic Institutional Review Board

• Reviews and monitors all Mayo studies
• Members include scientists, nurses, physicians,
  ethicists, chaplains, community members and others

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Institutional Review Board

• Reviews proposals
• Approves research studies
• Monitors safety of participants

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Informed Consent

• Process of learning the key facts about the
  research study
• Occurs before participation and continues
  throughout
• You may withdraw at any time
• Signature is not binding

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Study Activities

• X-rays
• Blood tests
• Counseling
• Medications

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Study Design

• Placebo
• Randomized
• Blinded/Masked
• Single/Multi-site

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Paid to Participate

• If consent form says remuneration provided, you
  will be paid to be in the study

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Cost

• Review consent form
• Check with doctor or insurance plan
• Medicare covers cost of qualifying studies
• Insurers/states may cover standard-care costs

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Benefits

• Access to promising new approaches
• Regular attention from a medical team
• Results may help others in the future

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Risks/Inconveniences

• May not be better than the standard treatment
• Unexpected side effects
• Required visits with the research team

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Weigh the Risks Benefits

• Mayo Clinics primary value is The needs of the
  patient come first
• All types of treatment contain risk

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Ask Questions

• Know what questions you want answered
• If you do not understand, say so
• If something does not seem right, speak up, ask
  about it

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Websites

• http//clinicaltrials.mayo.edu/
• http//www.clinicaltrials.gov/

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The Impact of Clinical Trials on the Quality of
Care of Native American Cancer Patients
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Native issues with inclusiveness
Why do they always want to experiment on us?
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Native issues with exclusiveness
Why arent Natives allowed to take part in those
types of studies?
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Importance of cancer care trials
Natives have the poorest survival from cancer in
comparison with other ethnicities
Possibly fewer side effects from newer treatments
Greater comfort in cases where the cancer itself
cannot be treated
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Cultural Perspectives and Cancer Diagnosis
1. White mans disease
2. Punishment (from your actions or a family
members actions)
3. Wear the pain to protect other members of
ones communities
4. Natural part of ones path and the lessons to
learn
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How do cultural perspectives of cancer / health
influence clinical trials?
Spiritual aspects of the disease are not
acknowledged within clinical studies
Hesitancy of some providers to collaborate with
Traditional Indian healer
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Importance of cancer care trials
To provide high-quality, up-to-date care for
todays cancer patients.
According to Native Survivors Network
preliminary findings, our patients currently
are not receiving the best care available ...
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Benefits / Drawbacks
Potential Benefits
Potential Drawbacks
Barriers
Access to
Transportation
on-going medical care
Child care
monitoring
Time off from work
routine follow-up
Time constraints
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Benefits / Drawbacks
Potential Benefits
Potential Drawbacks
All participants supposed to be treated the same
Individuals cultural, spiritual needs may not be
addressed / respected
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CULTURAL/SPIRITUAL NEEDS

• WHAT IS AN EXAMPLE OF A CULTURAL PRACTICE THAT
  MIGHT NOT BE ALLOWED IN A TREATMENT FACILITY
• A. COORDINATION WITH A MEDICINE MAN
• B. SMUDGE CEREMONY
• C. TIME FOR PRAYER

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Importance of cancer care trials
Some types of cancer trials are for people who do
not have cancer
High risk does NOT mean that you will get
cancer.
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Cherokee Nation and the STAR Trial

• STAR is the Study of tamoxifen and raloxifene
  for the prevention of breast cancer
• Cherokee Nation approved their tribal involvement
  in this trial to accrue high risk women.

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Native Cancer Information Resource Center
and Learning Exchange Native C.I.R.C.L.E. ht
tp//www.mayo.edu/nativecircle/