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Dynamic allocation and minimisation

Dynamic allocation moves away from having a pre-specified randomisation list and the allocation of patients evolves as the trial proceeds. The method looks at the current balance, in terms of the mix of patients and a number of pre-specified factors, and allocates the next patient in an optimum way to help redress any imbalances that exist at that time. [Pg.9]

For example, suppose we require balance in terms of sex and age ( 65 versus 65) and part way through the trial we see a mix of patients as in Table 1.1. [Pg.9]

CHOI BASIC IDEAS IN CLINICAL TRIAL DESIGN [Pg.10]

Since the publication of ICH E9 there has been considerable debate about the validity of dynamic allocation, even with the random element. There is a school of thought which has some sympathy within regulatory circles that supports the view that the properties of standard statistical methodologies, notably p-values and confidence intervals, are not strictly valid when such allocation schemes are used. As a result regulators are very cautious  [Pg.10]

CPMP (2003) Points to Consider on Adjustment for Baseline Covariates  [Pg.10]


See other pages where Dynamic allocation and minimisation is mentioned: [Pg.4]    [Pg.9]   


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Dynamic allocation

Minimisation

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