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For a given NI margin, utilizing a risk difference analysis approach, the sample size decreases as the endpoint rate decreases from 50%. However, if the endpoint rate drops below 15%, the potential for loss of clinically acceptable efficacy with a 10% NI margin may be judged too great, such that a smaller NI margin is appropriate. If a fixed NI margin of 10% is not supportable, then either a lower fixed NI margin eg, 7% or an odds ratio analysis approach is required . Either approach results in an increased study sample size. For example, a trial design assuming an ACM rate of 15% and a 10% NI margin requires 402 patients for the primary analysis. However, an ACM rate of 10% would most likely require a narrower 7% NI margin to avoid the possibility of an excessive loss of a clinically relevant treatment effect, thereby resulting in an increase in required enrollment to approximately 550 patients. Therefore, a clinically relevant endpoint having an occurrence rate of 15%20%, which would allow use of a 10% NI margin, would enable the study to have sensitivity to rule out clinically meaningful differences, with a decreased sample size. 3. Differences in ACM among the nonventilated HABP nv HABP, ventilated HABP v HABP, and VABP groups suggest that pooling their outcomes raises methodological issues. Because a clinically meaningful endpoint of symptom improvement plus survival for nv HABP is supported by the historical data for community acquired bacterial pneumonia CABP , nv HABP could be studied separately utilizing a patient reported outcome PRO instrument, thereby standardizing symptom collection . Given these considerations, sponsors of recent studies generously provided access to HABP/VABP datasets for further statistically rigorous evaluation.

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Activation mechanisms of human matrix metalloproteinases; regulationof the activity of human neutrophil gelatinase/type IV collagenase. June 3, 1993. 5. S. Department of Health and Human Services, Bethesda, Maryland. Hynda K.