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The ideas include the difference between explanatory and pragmatic orientation in clinical trial design, approaches to studying groups of patients with heterogeneous disease mechanisms, the importance of placebo responses, and the concept of "assay sensitivity" in clinical trials.
It also describes several ideas useful in designing trials, including the difference between explanatory and pragmatic orientation in clinical trial design, approaches to study groups of patients with heterogeneous disease mechanisms, the importance of placebo responses, and the concept of "assay sensitivity" in clinical trials.
8 There is a continuum rather than a dichotomy between explanatory and pragmatic trials.
Table 1 shows some key differences between explanatory and pragmatic trials.
The substantial differences between explanatory and pragmatic trials illustrate a paradigm shift to clinical practice.
Table 1 (see Additional file 1) provides a summary of the differences between explanatory and pragmatic trials.
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For randomized trials, the distinction between explanatory and practical or pragmatic is also often made [ 8- 10].
This article reviews key methodological considerations for clinical trials that utilize explanatory and pragmatic trial designs and relates these contrasting approaches to the interpretation of results from comparisons of oral versus long-acting injectable (LAI) antipsychotics in schizophrenia.
"Explanatory and Pragmatic Attitudes in Therapeutical Trials". Journal of Chronic Diseases 20 (8): 637–48.
In fact, there is a whole spectrum of explanatory and pragmatic trials [ 5].
Further explanatory and pragmatic intervention studies are required, to estimate the value, if any, of mite reduction strategies in mite sensitive asthmatic children with more severe disease.
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