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Selection bias in clinical trials.

K Antman, D Amato, W Wood

    Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
    |August 1, 1985
    PubMed
    Summary
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    High-risk sarcoma patients often avoid adjuvant doxorubicin trials, leading to poorer disease-free survival in non-randomized groups. This selection bias impacts treatment efficacy conclusions and generalizability of trial results.

    Area of Science:

    • Oncology
    • Clinical Trials
    • Biostatistics

    Background:

    • Adjuvant chemotherapy is a standard treatment for high-grade sarcomas.
    • Randomized controlled trials (RCTs) are crucial for establishing treatment efficacy.
    • Selection bias can compromise the generalizability of RCT findings.

    Purpose of the Study:

    • To analyze patient and physician factors influencing randomization in a sarcoma adjuvant doxorubicin trial.
    • To assess the impact of selection bias on disease-free survival outcomes.
    • To evaluate the generalizability of trial results.

    Main Methods:

    • Retrospective analysis of 90 eligible sarcoma patients.
    • Comparison of characteristics and outcomes between randomized and non-randomized patients.

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  • Statistical analysis of factors affecting randomization and disease-free survival.

    • Main Results:

    • 48% of eligible patients were not randomized due to physician choice or patient refusal.
    • Lower-stage patients were more likely to be randomized (65%) than higher-stage patients (37%).
    • Non-randomized patients exhibited inferior disease-free survival compared to randomized patients.

    Conclusions:

    • High-risk sarcoma patients, particularly those with higher stage or central lesions, were less likely to be randomized.
    • Selection biases in this trial led to differing conclusions on treatment efficacy between randomized and non-randomized groups.
    • Physician and patient selection biases can limit the generalizability of clinical trial results in sarcoma treatment.