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<p>In many disease areas, therapeutic intervention is designed to prevent clinical worsening of the disease, thereby increasing the quality and length of life for patients with life-threatening diseases. While this research hypothesis might be simple to state in non-statistical terms, there are many endpoints that can be used to provide insight to this question. For diseases that rapidly progress, intervention of a new therapy should delay clinical progression for the drug to be deemed efficacious. This suggests that the proportion of patients who experience clinical worsening while on an active study drug should be lower than the proportion experiencing clinical worsening in a control group. This presentation assumes the use of a Fishers Exact Test. The focus is on the structure of the input data set used with the FREQUENCY procedure to obtain the inferential statistics. In a one-sided setting, the structure and order of the treatment and response variables is essential to understanding whether a right-tailed or a left-tailed p-value is appropriate so that it is consistent with the underlying research hypotheses. This presentation uses a placebo-controlled clinical study to show how the order of the treatment and response variables impacts the statistical hypotheses associated with a one-sided Fishers Exact Test. While the hypotheses themselves might differ, the research question remains the same: Does the study drug reduce the incidence of clinical worsening?<br>
<br>
Bill Coar, Axio Research</p>
Session 1933
en
jeff.foxx@sas.com
<p>In many disease areas, therapeutic intervention is designed to prevent clinical worsening of the disease, thereby increasing the quality and length of life for patients with life-threatening diseases. While this research hypothesis might be simple to state in non-statistical terms, there are many endpoints that can be used to provide insight to this question. For diseases that rapidly progress, intervention of a new therapy should delay clinical progression for the drug to be deemed efficacious. This suggests that the proportion of patients who experience clinical worsening while on an active study drug should be lower than the proportion experiencing clinical worsening in a control group. This presentation assumes the use of a Fishers Exact Test. The focus is on the structure of the input data set used with the FREQUENCY procedure to obtain the inferential statistics. In a one-sided setting, the structure and order of the treatment and response variables is essential to understanding whether a right-tailed or a left-tailed p-value is appropriate so that it is consistent with the underlying research hypotheses. This presentation uses a placebo-controlled clinical study to show how the order of the treatment and response variables impacts the statistical hypotheses associated with a one-sided Fishers Exact Test. While the hypotheses themselves might differ, the research question remains the same: Does the study drug reduce the incidence of clinical worsening?<br>
<br>
Bill Coar, Axio Research</p>
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A One-Sided Fisher's Exact Test: A Tail of Clinical Worsening
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