By Ying Kuen Cheung (auth.), David Harrington (eds.)
This publication will learn present concerns and controversies within the layout of medical trials, together with themes in adaptive and sequential designs, the layout of correlative genomic experiences, the layout of experiences during which lacking facts is predicted. every one bankruptcy may be written via knowledgeable undertaking examine within the subject of that bankruptcy. As a set, the chapters will be meant to function a information for statisticians designing trials.
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Additional info for Designs for Clinical Trials: Perspectives on Current Issues
Chapter 8 of Rosenberger and Lachin (2002) reviews classical developments in reasoning about the efficiency of stratified randomization in the context of stratified analyis. It is shown that in large trials, efficiencies of posthoc stratified analyses are not substantially increased for trials in which stratified (as opposed to simple) randomization was used for treatment allocation. In small trials, stratified randomization does yield efficiency benefits, but the number of strata that can be feasibly used in small trials is often quite small.
When unequal treatment allocations are desired, we consider imbalance to be the difference between the treatment allocations as given and the ideal (or expected) allocations defined by the randomization scheme. A major motivation for concern with imbalance is its effect on efficiency of inference on the trial. Under complete randomization, it is possible that substantial imbalance occurs, and only a small number of individuals receive one of the treatments. In this case, uncertainty about the effect of the rarely used treatment can make it very difficult to obtain a clear interpretation of the difference between the treatments.
From a mathematical viewpoint, coherence is a pointwise property because it involves every possible dose assignment sequence in the sample space. 2a shows an outcome sequence with an incoherent escalation, and Fig. 2b with an incoherent deescalation; the designs that generate these sequences are incoherent designs. 2c shows a coherent outcome sequence; but to establish coherence of the generating design for N patients, all 2N outcome sequences need to be verified as coherent. It is almost instinctive to enforce coherence as an ethical criterion in practice.
Designs for Clinical Trials: Perspectives on Current Issues by Ying Kuen Cheung (auth.), David Harrington (eds.)