|
|
Question 7.2.1
Without having done the second
study, could one have drawn the same conclusion? That is,
could one just display the 12/40 patients in the first trial
with clonidine response surpassing placebo and infer that
there is a clonidine-response subset?
 
Question 7.2.2
Based on the prospectively
gathered data from the enriched second trial (Figure 7.2),
the researcher concluded that there is a subset of patients
with diabetic neuropathy pain who are true clonidine responders.
Which of the following critiques are valid?
 | It is not
statistically appropriate to pick responders and then
enter them in another trial. |
 | A limitation
of the second trial is that one cannot generalize to
the overall population of patients with diabetic neuropathy
pain. |
 | Repeated
exposures to a drug with side effects (like clonidine)
make it more likely that patients will become unblinded,
and give rise to a false-positive result. |
|