Fixed effects model with Group term [Two-Stage / GS Designs]

posted by mittyri – Russia, 2016-10-09 13:27  – Posting: # 16708
Views: 26,833

Dear All,

Now I'm using the model from 2-stage design (without Period term):
    muddle <- lm(log(Var)~Group+Seq+Seq*Group+Subj%in%(Seq*Group)+Per%in%Group+Trt, data=data)
    # like in 2 stage design;
    # I know that Subject %in% ... is just a Subject, I didn't change this term for consistency


BTW the question is still there, because the output is the same as above (PE and MSE are different)
Also please note that the Group factor is extremely significant
When I run this dataset for FDA Model I in Phoenix (don't know the code for R):
  Dependent Hypothesis Numer_DF Denom_DF        F_stat     P_value
1   Ln(Var)        int        1       14 3.1047428e+03 0.000000000
2   Ln(Var)      Group        1       14 9.9615453e-01 0.335181899
3   Ln(Var)        Seq        1       14 9.7094813e-01 0.341167964
4   Ln(Var)  Group*Seq        1       14 5.7364354e-02 0.814182229
5   Ln(Var)  Group*Per        2       14 3.2110481e+00 0.071153125
6   Ln(Var)        Trt        1       14 3.4404496e+00 0.084798088
7   Ln(Var)  Trt*Group        1       14 2.3942317e-01 0.632200219

The Group factor is faraway from significant level.

It could be a nightmare for Russia, where the experts insist on the Group term in the model, but all other things should be like in EMA Guideline with all factors as fixed (does someone realize how many studies will be failed? The experts suggest not to pool the groups in this case like the FDA Guidance states!)

Kind regards,
Mittyri

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