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A psychological perspective for double-blind trials.

S M Zifferblatt, C S Wilbur

    Clinical Pharmacology and Therapeutics
    |January 1, 1978
    PubMed
    Summary
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    Blind breaking in clinical trials is common due to prolonged ambiguity. Strategies to manage this include better medical care, screening, and fostering an environment for open disclosure.

    Area of Science:

    • Clinical Trials
    • Medical Ethics

    Background:

    • Long-term clinical trials pose challenges for maintaining participant blinding.
    • Participants at risk may experience significant ambiguity regarding their health status.

    Purpose of the Study:

    • To identify factors contributing to blind breaking in clinical trials.
    • To recommend strategies for managing blind breaking effectively.

    Main Methods:

    • Analysis of factors influencing participant and staff behavior in blinded trials.
    • Review of clinical trial protocols and ethical considerations.

    Main Results:

    • Participant ambiguity and staff role confusion are key drivers of blind breaking.
    • The desire for optimal medical care can lead participants to breach blinding.

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    Conclusions:

    • Improving medical care quality and participant screening can reduce blind breaking.
    • Creating an open clinical environment is crucial for accurate disclosure and trial integrity.