Benefit/Risk Assessment in Prevention Trials
1
Joseph P. Costantino,
Joseph P. Costantino
University of Pittsburgh, Pittsburgh, PA, USA
Search for more papers by this authorJoseph P. Costantino,
Joseph P. Costantino
University of Pittsburgh, Pittsburgh, PA, USA
Search for more papers by this authorFirst published: 15 July 2005
Abstract
Benefit/risk assessment (B/RA) is a mathematical procedure to estimate the probability of detrimental outcomes, beneficial outcomes and the net-effect anticipated from exposure to a given agent or procedure. B/RAs of health-related outcomes are used for public health planning, decision-making regarding health care financing, and therapeutic decision-making in clinical practice. Information obtained from B/RAs based on findings from controlled clinical trials, particularly those with double-masking of treatment, are most informative for health care planning and decision making because such information is less likely to be bias than is information obtained from observational studies. Thus, B/RAs in prevention trials are an excellent source of information to use as the basis for health care planning and decision-making. Applications of R/BA in prevention trials are performed as supplements for planning, monitoring and analyzing the trial. These applications can be categorized into three types of assessments. This article provides a description of the three types of assessment performed in prevention trials, defines the statistical algorithms used for each type of assessment and discusses several key methodological and practical issues involve with the application of B/RA to health-related outcomes.
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