Print

Print


Edie: The post just prior to yours was a similar request from Joe (who had
the original question yesterday). His request was off list so you didn't see
my response. You sound as if you're in pretty good shape and are beyond most
if not all the problems I encountered. At this point, it looks like you will
take over as resident 'expert'

Joe: The best advice I can give you is to be proactive, based upon my own
experience. The contact at the study is a young, nice accommodating woman
named Stephanie. As nice and accommodating as she is, she appears to be
overloaded and working with little guidance. Examples:
1. Although I called every two weeks after I confirmed their receipt of my
records from my Neuro, they waited until the day before the committee was to
meet to review  my records to do a preliminary review. At that point they
decided they needed something else (I'll elucidate below) and if it hadn't
luckily been available I would have missed that session of the review. As
best I can tell, reviews do not take place too frequently.
2. They apparently require that the stage of your disease be rated (on
whatever the scale is called - I'm away from home so I don't have access to
my own notes or records) and If you haven't been rated by your neuro (I also
don't know how current this rating has to be -- you need to ask), you will
have to be.
3. I finally got all that out of the way some 4 months or so after my
original submittal.
Stephanie and I were up to scheduling a date for me to go to Philadelphia for
a final evaluation and I believe, the concomitant beginning of the program
for me. We agreed on a date and then she said she needed to review my meds
once again. When I told her that I had just started a (voluntary) program to
replace my Sinemet with Requip, she had to cancel my appointment because the
protocol demands that your medications be stable for three months prior to
evaluation and start (and by the way, have to remain stable during the trial
or you have to drop out). I suggested to her as nicely as I could (I
certainly didn't want to be antagonistic at this point), that had I known
that, I never would have started the change in my medication: that the change
was voluntary, not mandatory; and that I was very disappointed since I wanted
very much to enter the study. Since we had become such frequent talking
partners, she was somewhat empathetic but had no choice but to follow the
protocol guidelines. I suggested that for the sake of people like me it would
be helpful if they published the guidelines and sent it along with the
introductory literature so that where possible, we could insure our own
conformance. She agreed but allowed that she could only do what she was told
to do.

So instead of entering the study in mid December, I am now consigned to wait
until I finish my drug experimentation which will probably put me int an
April time frame.

Joe, these are only my experiences and I'm sure that other glitches have
developed with other applicants. Probably as many glitches as there are
applicants. Stay on top of it and ask every question you can think of until
you finally get an appointment.

Good luck. With any luck, perhaps we will become fellow statistics.

Paul H. Lauer