They have to automate the process. They cannot monitor even a small
group of people effectively day after day during the trial without
automation. I would rather see this automation process get off the
ground now instead of after phase 1 of the trial is finished. At
least the are working with some kind of vision and greater plan in
mind. My fingers are crossed with this one.
--- In nathanfaustmantrials@yahoogroups.com, "stilltypeone"
<stilltypeone@...> wrote:
>
> Sue, thanks for the info. I am still baffled that they chose to
> spend time and money on the automation process, when it may be a
> moot point.
> If they can count T cells from hundreds of mice, can they not do
the
> same for such a small sample of humans?
>
>
> --- In nathanfaustmantrials@yahoogroups.com, Sue root
> <susan_root@> wrote:
> >
> > The procedure to separate and count the targeted T cells from
> whole blood samples in humans takes 1 ½ days by hand. Seeing that
> they plan to ultimately take blood samples every other day from the
> patients to monitor the effect, and they will plan to have 40
> patients in the trial with controls, the automation will make this
> possible in a timely manner by decreasing the procedure to only
> about 6 hrs. More importantly, standardizing dosing in mice is much
> less of an issue compared to humans, even if we're talking 40 people
> > Even though the NOD mouse is the best known animal model for type
> I diabetes, when dosing in mice, one doesn't have to deal with
> variables such as body weight. The groups of mice are born at the
> same time, are the same size, and develop diabetes roughly the same
> time. Therefore, being able to standardize the dosing of BCG in a
> group of humans with such variables, will be a key factor for
> success.
> > What we do know is that the NOD mice have the same 2 defects
> found in humans with type I diabetes and the treatment that Dr.
> Faustman used targets and eliminates these defects.
> >
> >
> > stilltypeone <stilltypeone@> wrote:
> > Patsy, I think you are misunderstanding what I am
> inferring.
> > The point I am making is why spend so much time and money on a
> > automation process that, in the end may end up as useless. Kind
of
> > like the "cart before the horse". Why not do the initial trial by
> > hand, as the mouse trials were done. If sucessful, then move on
to
> > scale this up to a larger group trial.
> > I would not expect death from BCG injections, as it is used in
> huge
> > quantities for bladder cancer.
> > The begining trial as I understand it will be 40 individuals. I
> > consider that "small". I realize that is a relative term.
> > If asking questions is "grumbling" then I am guilty.
> >
> > --- In nathanfaustmantrials@yahoogroups.com, Patsy Van Huyck
> > <patsy@> wrote:
> > >
> > > The answer in short is because if a mouse dies, nobody cares.
> > Just
> > > think if the "small human trial" was a failure either due to
> huge
> > > complications or due to the lack of results. Do you think that
> > they
> > > would just get to try again with another dose? The assay is
very
> > > important so that the trial can be successful, and we can then
> > move to
> > > the next stage.
> > >
> > > We all want the cure to have been in 2002, but dealing with the
> > FDA is
> > > tediously slow. Grumbling isn't going to get the research done
> > any more
> > > quickly.
> > >
> > > Patsy
> > >
> > > >
> > > > Re: NEJM Correspondence
> > > >
> >
>
<http://groups.yahoo.com/group/nathanfaustmantrials/message/245;_ylc=
> >
>
X3oDMTJxMmg3MXB1BF9TAzk3MzU5NzE1BGdycElkAzE2NDEyMTQ1BGdycHNwSWQDMTcwN
> >
>
TA2MTY2MgRtc2dJZAMyNDUEc2VjA2Rtc2cEc2xrA3Ztc2cEc3RpbWUDMTE3MDU4NDUyMQ
> > -->
> > > >
> > > >
> > > >
> > > > Posted by: "stilltypeone" stilltypeone@
> > > > <mailto:stilltypeone@?Subject=%20Re%3A%20NEJM%
> > 20Correspondence>
> > > > stilltypeone <http://profiles.yahoo.com/stilltypeone>
> > > >
> > > >
> > > > Sat Feb 3, 2007 6:57 pm (PST)
> > > >
> > > > Sue, can we agree that these trials will not proceed until
> > > > the "automated assay" is completed?
> > > > Did Faustman have this automated assay during the mouse
trials?
> > > > I am guessing the answer is no.
> > > > So, why the need for automation for a small human trial?
> > >
> >
>