Biomarker-Based Methods for Determining Noncompliance in a Prevention Trial

    December 2002 in “ Controlled Clinical Trials ”
    Donna K. Pauler, Kathryn B. Gower, Phyllis J. Goodman, John J. Crowley, Ian M. Thompson
    TLDR Simple methods using DHT levels effectively assess compliance.
    The study investigated biomarker-based methods for determining noncompliance in the Prostate Cancer Prevention Trial (PCPT), which involved 18,000 men over 7 years to test finasteride for prostate cancer prevention. Compliance was primarily assessed through pill counts, but a substudy involving 5% of participants used 5α-dihydrotestosterone (DHT) levels as a biomarker. The study found that simple absolute threshold rules for monitoring compliance using DHT levels were as effective as more complex methods. The results suggested that these simpler methods could provide accurate compliance assessments without the need for more frequent or complex measurements.
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