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Phase I trials of biological response modifiers.

R V Smalley, R K Oldham

    Drugs Under Experimental and Clinical Research
    |January 1, 1986
    PubMed
    Summary

    A new format for phase I trials of biological response modifiers (BRM) was developed from recent National Cancer Institute studies. This format is being used in ongoing trials of interferons and will be evaluated later.

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    Area of Science:

    • Oncology
    • Immunology
    • Clinical Trial Design

    Background:

    • Biological response modifiers (BRM) are critical in cancer therapy.
    • Phase I trials are essential for evaluating novel cancer therapeutics.
    • Previous trial designs for BRM require refinement.

    Purpose of the Study:

    • To develop an optimized format for future phase I trials of BRM.
    • To analyze the application of this new format in ongoing trials.
    • To establish a framework for evaluating BRM therapeutic strategies.

    Main Methods:

    • Analysis of recently conducted phase I trials sponsored by the BRM Program.
    • Development of a standardized trial format for BRM agents.
    • Application of the developed format in ongoing phase I trials of recombinant interferons.

    Main Results:

    • A novel format for conducting phase I BRM trials has been established.
    • The format's evolution and implementation in interferon trials are documented.
    • The methodology is currently being tested in active clinical studies.

    Conclusions:

    • The developed format provides a structured approach for future BRM phase I trials.
    • Ongoing trials with recombinant interferons will assess the format's efficacy.
    • Further evaluation is planned to validate the proposed trial methodology.

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