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Decision-making: The benefits and challenges of participating in clinical trials

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Decision-making: The benefits and challenges of participating in clinical trials

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    1. Decision-making: The benefits and challenges of participating in clinical trials Deborah McGuire, PhD, RN, FAAN Professor & Coordinator, Oncology Specialty Track

    2. Topics to be discussed Why should a clinical trial be considered? What are the benefits and challenges for patients and families? What are the benefits and challenges for health care professionals?

    3. Why should a clinical trial be considered? “…well-designed experimental research is an appropriate basis for clinical care.” (Piantadosi, 1997)

    4. Here are some examples Oranges & lemons ? prevented scurvy 1747 Ether & chloroform ? allowed people to be put to “sleep” for operations, then awakened 1840s Penicillin ? cured infections 1943 Medications ? relieved effects of diabetes and high blood pressure ? thereby preventing more serious consequences 1900s Anti-retroviral and protease inhibiting drugs ? converted HIV/AIDS from a swift and deadly killer to a manageable chronic illness 1990s-present

    5. What about cancer? Without clinical trials, Lance Armstrong would not have lived to win ANY bicycle race! Without clinical trials, a majority of children with cancer would NOT be cured!

    6. Summary Clinical trials teach health care professionals What the best care is Who to give it to How to give it Clinical trials are one of the major ways in which “medical breakthroughs” are made Patients may be cured, or live longer with cancer Quality of life can be dramatically improved Families also experience positive benefits

    7. What are the challenges and benefits for patients and families? “How do I know I am not being used as a guinea pig?” “If this was a good idea, wouldn’t my doctor have told me about it?”

    8. The sad facts Many people do not even know about clinical trials (85%) If they do, they think they will be merely guinea pigs Few people realize there are benefits Fewer participate: 3% Australians 2-3% Americans Minorities and under-served populations

    9. Benefits to patients and families Access to the newest treatments Highest standard of care Potential for personal medical benefit Careful monitoring and early diagnosis of any problems Priority on protecting patient safety Close relationship with health team Active role in own health care Satisfaction of contributing to knowledge that may help others

    10. Challenges to patients and families Frequent visits to doctor’s office Inconvenience and hardship if distances are involved Family members are opposed to it Possible minor or major side effects Potential for no positive response New treatment may be no better than standard of care Even if new treatment is good, it may not work for everyone

    11. What are the challenges and benefits for health care professionals? “Where are the trials being done?” “Will my patients return afterwards?” “Clinical trials make a lot more work for us.”

    12. Challenges for health care professionals Lack of awareness or availability Reluctance to “lose” patients Concern about how much additional work would be involved Lack of faith in the process Preference for own treatment Afraid to suggest it to patients Rarely questioned by patients

    13. Benefits for health care providers “Doing the right thing” for the patient Facilitating access to the newest treatments Contributing to advancement of medical knowledge Keeping oneself current Practicing evidence-based care

    14. Be your own advocate!

    15. Some helpful websites www.cancersa.org.au www.ctc.usyd.edu.au/6registry/regl.shtml www.cancercouncil.com.au/cancertrials/index.htm www.nhmrc.gov.au www.ludwig.edu.au/cara2/index2.html http://www.cancer.gov/clinicaltrials/ www.eortc.be

    16. Understand the realities All clinical trials have “eligibility” criteria that say who may join There may not be any trials for your particular cancer You may have to travel to get in a clinical trial

    17. Things to ask What is the purpose? What is the evidence the treatment might work? What tests and treatments are involved? What are the side effects? What are the benefits? How will my safety be protected? How is it different from what I would get if I did NOT participate? Who will pay for the treatment? How will I know if the treatment works? Can I quit if I want to?

    18. What if more people joined trials? “Low participation in cancer clinical trials exerts a powerful impact on the delivery of high quality cancer care.” (Hubbard et al., 2002) Higher participation could more rapidly result in more, and better, cancer treatments People with cancer would live longer, and live better

    19. Some final thoughts… Sometimes what we won’t do for ourselves, we will do for our children Why should that be? Why can’t it change? You are your own best friend!

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