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    The Parents of A 21-Year-Old Woman Challenged The FDA. They Took The Authority To

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    2123 cndpbcthuoc
    The parents of a 21-year-old woman who died of cancer challenged the FDA in court, believing their daughter may have survived if given access to an experimental cancer drug her doctor recommended. While many terminally ill patients think clinical trials aim to cure them, the main objective is answering scientific questions about a drug's safety and efficacy. The FDA maintains that rigorous clinical trials are needed to determine a drug's safety and efficacy, and that it would be difficult to recruit trial participants if patients could access experimental drugs without enrolling.

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    The Parents of A 21-Year-Old Woman Challenged The FDA. They Took The Authority To

    Uploaded by

    2123 cndpbcthuoc
    53 views1 page
    The parents of a 21-year-old woman who died of cancer challenged the FDA in court, believing their daughter may have survived if given access to an experimental cancer drug her doctor recommended. While many terminally ill patients think clinical trials aim to cure them, the main objective is answering scientific questions about a drug's safety and efficacy. The FDA maintains that rigorous clinical trials are needed to determine a drug's safety and efficacy, and that it would be difficult to recruit trial participants if patients could access experimental drugs without enrolling.

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    The parents of a 21-year-old woman who died of cancer challenged the FDA in court, believing their daughter may have survived if given access to an experimental cancer drug her doctor recommended. While many terminally ill patients think clinical trials aim to cure them, the main objective is answering scientific questions about a drug's safety and efficacy. The FDA maintains that rigorous clinical trials are needed to determine a drug's safety and efficacy, and that it would be difficult to recruit trial participants if patients could access experimental drugs without enrolling.

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    © All Rights Reserved
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    53 views1 page

    The Parents of A 21-Year-Old Woman Challenged The FDA. They Took The Authority To

    Uploaded by

    2123 cndpbcthuoc
    The parents of a 21-year-old woman who died of cancer challenged the FDA in court, believing their daughter may have survived if given access to an experimental cancer drug her doctor recommended. While many terminally ill patients think clinical trials aim to cure them, the main objective is answering scientific questions about a drug's safety and efficacy. The FDA maintains that rigorous clinical trials are needed to determine a drug's safety and efficacy, and that it would be difficult to recruit trial participants if patients could access experimental drugs without enrolling.

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    The parents of a 21-year-old woman challenged the FDA.

    They took the authority to


    court after their daughter had died of cancer. The parents firmly believe that their daughter might
    have had a chance of surviving if she had been given access to a potentially life-saving
    experiemental cancer drug that her doctor had recommended. Many terminally ill people fall
    victim to the “therapeutic misconception” that the objectives of trials is to cure them. In truth,
    clinical trials are mainly aimed at answering scientific questions. In general, their goal is to
    gather statistics to determine whether an experimental drug is safe and effective.
    On the whole, subjects in a trial must be willing to be randomly assigned to either the
    group which receives the unapproved medication or the one which gets a placebo. This is the
    only way to make sure clinical trials serve a scientific purpose. Subjects have to be aware that the
    pharmaceutical company which is sponsoring the clinical trial can stop the trial at any time.
    Do terminally ill patients have the legal right to try to prolong their lives by taking
    experimental drugs? The FDA has a clear position on this subject. It maintaisn that it would be
    difficult to find a sufficient number of patients to participate in clinical trial if it were possible to
    obtain the drug without actually being a subject in a trial. The safety and efficacy of a drug can
    only be determined by conducting rigorous clinical trials, according to the FDA.
    QUESTIONS
    T 41. The 21-year-old woman whose parents challenged the FDA did die of cancer.
    F 42. Before her death, she used to administer a potentially life-saving experimental cancer
    drug.
    NG 43. The total cost of this treatment was paid by the drug manufacturer.
    NG 44. If the girl had used this experimental drug, her illness could have been better.
    T 45. To cure the terminally ill patients is one therapeutic msiconception. T
    T 46. Answering scientific questions concerning one particular medicine or treatment is the
    main purpose of any clinical trial.
    T 47. Gathering statistics to determine safety & efficacy is a must in any clinial trial.
    48. Randomization means that the participants get either the experimental drug or the placebo
    without knowing for sure which was being given. NG
    NG 49. Those participating in a clinical trial just desire to obtain the drug for their terminal
    illness.
    NG 50. FDA only accepts any drugs or treatments to be available on market once their safety &
    efficacy have been proved.

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