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    A Unified Approach to the Use of Human Clinical Studies: Problems with Data Aggregation

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    In this report, the author has set forth his approach to aggregating data from diverse studies designed to assess the impact of pollutant gases on pulmonary function. In addition, several key problem areas have been highlighted by example. The author has confined himself to studies conducted on humans under controlled exposure conditions; he reasoned that initial efforts should be limited in scope because this approach necessitates selecting out of a vast number of studies those few that are considered uniformly sound enough to serve as the quantitative foundation for risk analysis and as the norm to which future results will be compared. Since the selection process must combine methods that are both objective and subjective, particularly when criteria for study exclusion are derived, valuable counsel was sought and received from colleagues who, by virtue of their training and experience, could aid in developing the assessment format.


    Inhalation, inhalation toxicology, air pollution, clinical studies, multipollutant studies

    Author Information:

    Colucci, AV
    Director, Smoking and Health Division, R. J. Reynolds Tobacco Co., Winston-Salem, NC

    Committee/Subcommittee: D22.05

    DOI: 10.1520/STP32851S