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Biostatistics in Clinical Research

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Biostatistics in Clinical Research

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    1. Biostatistics in Clinical Research

    2. Outline Example Statistical Issues in Clinical Research Prospective vs. Retrospective Studies Size and Power of Clinical Research Studies

    3. Example : Statistical Issues

    4. Statistical Aspects of Clinical Research Target population / sample / generalizability. Quantification of hypotheses, case definitions, endpoints. Control of bias; confounding. Comparison/control group. Randomization, blinding. Justification of study size: power, precision, other. Use of data from non-completers. Methods of analysis. Mid-study analyses.

    5. Major Study Designs

    6. Example: Study Size for a Clinical Trial

    7. Extreme Outcome #1

    8. Extreme Outcome #2

    9. More Realistic Possible Outcome I

    10. More Realistic Possible Outcome II

    11. More Realistic Possible Outcome III

    12. More Realistic Possible Outcome IV

    13. Factors for Study Size: So Far

    14. Possible Errors in Study Conclusions

    15. Factors for Study Size: Final

    16. Graphical Representation of Power

    17. www.stat.uiowa.edu/~rlenth/Power

    18. Software Output: Power with N=100 Subjects/Group

    19. Number of Subjects and Power to Detect Oatmeal Effect of 3 Points in Cholesterol

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