First Experience Working on Pharmaceutical Cases
In approximately March of 2006, I met Dr. Hersh’s father, an optician in the
men’s room of the building, and he expressed concern that some of his
patients were experiencing severe eye infections called Fusarium Keratitis. As
it turned out, there were patients worldwide experiencing the same illness. It
was an outbreak, and some patients were losing their vision. It was occurring
in 33 different States of the US as well as in Hong Kong and Singapore. New
Jersey had reported three cases to the CDC by March 2006, Chang et al. 2006.
Proper Use of Statistical Packages
MMRM analysis is preferred in psychiatric clinical research when using
repeated measures, not necessarily difference scores. There are several
limitations due to the relationship between baseline and repeated measures
mean, referred to as covariate time interaction. Neither TRD 3002 nor 3001
account for this factor, referred to as interaction, Schuler, 2022. Schuler’s
paper is well supported with mathematical simulations and, unfortunately,
shows the inherit weakness of using MMRM models for analyzing clinical
trials without controlling for time interactions. The other issue often found in
clinical studies is when MMRM is used when partial data are excluded, i.e.,
dropout data. This is a misuse of MMRM since it can result in lower power
and larger confidence intervals when time interactions are not considered.