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Clinically significant adverse effects in a Phase 1 testing program.

C J Zarafonetis, P A Riley, P W Willis

    Clinical Pharmacology and Therapeutics
    |August 1, 1978
    PubMed
    Summary
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    Phase I clinical trials in prison volunteers show a low incidence of significant medical events. Over 12 years, clinically significant events occurred rarely, indicating a favorable safety profile for early drug development.

    Area of Science:

    • Clinical Pharmacology
    • Drug Safety
    • Human Subject Research

    Background:

    • Phase I drug testing is crucial for assessing early safety.
    • Normal volunteers are essential for understanding drug effects without confounding disease factors.
    • Prison populations have been utilized for clinical trials, necessitating safety evaluations.

    Purpose of the Study:

    • To report the safety experience of a 12-year Phase I drug testing program.
    • To quantify the incidence of significant medical events in normal prison volunteers.
    • To assess the overall risk-benefit profile of early-phase drug development in this population.

    Main Methods:

    • Analysis of 12 years of data from a Phase I drug testing program.
    • Inclusion of 29,162 participants across 805 protocol studies.

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  • Systematic recording and categorization of all significant medical events, including adverse drug reactions and complications.

    • Main Results:

    • A total of 64 significant medical events were recorded over 614,534 subject days.
    • 58 events were classified as adverse drug reactions, with complete recovery.
    • 6 events were complications, including one fatality (cerebrovascular hemorrhage) and one case of residual hip changes.

    Conclusions:

    • Clinically significant medical events in this Phase I program occurred infrequently (1 per 9,602 subject days).
    • The overall safety profile suggests that early drug development in normal prison volunteers can be managed with minimal risk.
    • The study provides valuable data on the safety of conducting clinical trials in this specific volunteer group.