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Related Experiment Videos

Randomized phase II clinical trials.

R Simon, R E Wittes, S S Ellenberg

    Cancer Treatment Reports
    |December 1, 1985
    PubMed
    Summary
    This summary is machine-generated.

    Randomized phase II trial designs are evaluated, finding that randomizing new agents or schedules is valuable. This approach offers advantages over traditional methods for selecting effective cancer therapies.

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    Area of Science:

    • Clinical trial design
    • Oncology research
    • Statistical methodology

    Background:

    • Phase II trials are crucial for evaluating new cancer treatments.
    • Variability in phase II trial results can impact treatment selection.
    • Existing designs may not be optimal for identifying effective therapies.

    Purpose of the Study:

    • To review sources of variability in phase II trial outcomes.
    • To present and evaluate randomized designs for phase II testing.
    • To explore alternatives to traditional hypothesis testing for new agents.

    Main Methods:

    • Review of existing phase II trial designs.
    • Evaluation of randomized designs comparing new agents or schedules.
    • Presentation of ranking and selection methodologies.

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  • Sample size calculations for proposed designs.

    • Main Results:

    • Phase II designs with standard therapy controls are often not broadly useful.
    • Randomized designs among new agents/schedules are scientifically and logistically valuable with adequate patient accrual.
    • Ranking and selection offers advantages over testing for therapeutic equivalence.
    • Randomized designs with early stopping rules are proposed for combination studies.

    Conclusions:

    • Randomized designs comparing new agents or schedules are recommended for phase II trials.
    • Ranking and selection provides a powerful alternative for evaluating multiple treatment options.
    • Further research into adaptive designs, including early stopping, is warranted for phase II studies.