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Related Experiment Videos

Ethics and designs: laetrile trials as an example

G R Newell, N M Ellison

    Cancer Treatment Reports
    |February 1, 1980
    PubMed
    Summary

    The National Cancer Institute investigated Laetrile therapy for cancer patients. This retrospective analysis of self-reported benefits aimed to determine if further clinical trials for Laetrile are warranted.

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    Area of Science:

    • Oncology
    • Cancer Therapy Research

    Background:

    • Laetrile (amygdalin) is a controversial cancer treatment.
    • The National Cancer Institute (NCI) sought to evaluate its efficacy.

    Purpose of the Study:

    • To retrospectively analyze cases of cancer patients reporting objective benefit from Laetrile therapy.
    • To determine if there is sufficient evidence to warrant further clinical trials of Laetrile.

    Main Methods:

    • Solicitation of patient cases through nationwide mailings, press publicity, and advocacy groups.
    • Retrospective analysis of medical records of patients who believed they experienced antitumor benefit.
    • Application of NCI-standard response criteria for investigational agents.

    Main Results:

    • Analysis focused on patients who volunteered their cases and reported perceived benefits.
    • The study was uncontrolled, focusing only on positive responders.
    • Data were insufficient to determine a definitive response rate for Laetrile therapy.

    Conclusions:

    • The retrospective evaluation aimed to identify potential hints of objective benefit from Laetrile.
    • Findings were intended to inform decisions regarding the initiation of controlled clinical trials.
    • Further investigation was considered based on the collected data.
    Keywords:
    National Cancer Institute

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