Statistical analysis plan for the motor neuron disease systematic multi-arm adaptive randomised trial (mnd-smart)

HIGHLIGHTS

  • who: Richard A. Parker from the error rate control to pairwise error control (ie. no adjustment for multiplicity). This change was made without any knowledge of unblinded data from the trial and before any interim analysis had been performed. Therefore, the updated version of the protocol (version, .0, November, ) specifies that we will not adjust for multiplicity where this is specifically due to having multiple treatment arms of different investigational drugs, and instead we will only seek control of the pairwise type I error rates where relevant. No multiplicity adjustment will be applied to any analyses (interim . . .

     

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