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Alpha calculus in clinical trials: considerations and commentary for the new millennium

✍ Scribed by Lemuel A. Moyé


Publisher
John Wiley and Sons
Year
2000
Tongue
English
Weight
103 KB
Volume
19
Category
Article
ISSN
0277-6715

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✦ Synopsis


Regardless of whether a statistician believes in letting a data set speak for itself through nominal p-values or believes in strict alpha conservation, the interpretation of experiments which are negative for the primary endpoint but positive for secondary endpoints is the source of some angst. The purpose of this paper is to apply the notion of prospective alpha allocation in clinical trials to this di$cult circumstance. An argument is presented for di!erentiating between the alpha for the experiment (&experimental alpha' or #

) and the alpha for the primary endpoint (primary alpha, or .

) and notation is presented which succinctly describes the "ndings of a clinical trial in terms of its conclusions. Capping # at 0.10 and . at 0.05 conserves sample size and preserves consistency with the strength of evidence for the primary endpoint of clinical trials. In addition, a case is presented for the well de"ned circumstances in which a trial which did not reject the null hypothesis for the primary endpoint but does reject the null hypothesis for at least one of the secondary endpoints may be considered positive in a manner consistent with conservative alpha management.


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Discussion for ‘Alpha calculus in clinic
✍ Gary G. Koch 📂 Article 📅 2000 🏛 John Wiley and Sons 🌐 English ⚖ 43 KB 👁 2 views

The paper by Moyà e [1] provides useful discussion for some important statistical issues concerning the possibly complicated ways in which multiple comparisons across primary and secondary endpoints can a ect the results from clinical trials. How to balance tolerable in ation of type I error against