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GSK’s
Avandia in Alzheimer’s
Pete
Mitchell’s Hot Targets article (Pharma DD
Sept./Oct. 2006) had a few factual errors.
Avandia was tested in 511 patients [not 100] and
those without an APOE4 allele [more than half]
exhibited benefit with all doses tested, while
the placebo got worse. The findings in the APOE4
carriers was also interesting in that there may
be a possible dose effect, with higher doses of
drug needed.
Similarly
there is a strongly supported mitotoxic
hypothesis to support the mode of action of
Avandia in treating Alzheimer’s disease. It
supports the neuropathology hallmarks as the
consequence of decreased metabolic utilization
of glucose and oxygen. A major Phase III program
of several registration studies has already been
started.
Allen
D. Roses, MD
Senior Vice President, Pharmacogenetics
GlaxoSmithKline
Clinical
Trials: Location Matters
I
applaud your publication of the article
“Pharmas Pickier About Trial Sites” by
Laurie Sullivan in the Clinical Connection
section of the Sept./Oct. 2006 issue of Pharma
DD. When I had responsibility for clinical and
technical operations within the pharmaceutical
industry and running my own contract research
organization, we routinely did a
“post-mortem” on clinical trials. The
exercise is categorically similar to an
operations research problem, where one wants to
optimize output by tweaking input variables. It
is a learning exercise to identify what was done
well, what was done not so well and how we could
improve the next generation of clinical trials.
Quality
clinical investigations start with quality
protocol development and require quality in all
areas of operations, in a time and
cost-efficient manner. A most important aspect
is choice of investigational sites. Choosing
investigational sites with a demonstrated track
record of quality productivity accrues benefits
to whether the objective of the investigation
can be answered from the data collected.
Keep
up the good work.
Karl E. Peace, Ph.D.
Senior Research Scientist & Professor
Georgia Southern University |
