trial news

[wyndywyo]

http://www.clinicaltrials.gov/ct2/show/NCT00528528?term=telaprevir&rank=2

This is pretty close to the study I will be in with the primary difference is that there will be 500 non-naive patients WORLD WIDE - 6 in my group, with only 3 of us non-responders.  The other 3 are considered relapsers, those who cleared and detectable viral levels have

Comments

[3g0]

Don't worry - your distance to/from the clinic is probably not part of their algorithm in the randomization at all, in fact to do so would create a kind of statistical bias called selection bias that would limit the generalizability of their results. Trials are, in fact, behooved by having a diverse sample pulled from a lot of different geographical locations. For the randomization, the sponsoring company will likely assign numerical weights to you based upon some biological criteria, and then you'll get truly randomized via algorithm.

It's possible that they are implementing a kind of failsafe arm on the trial. They do that a lot with oncology products - usually they will conduct the randomization at baseline, and then at some predetermined time afterward, assess the progress of patients on placebo vs. investigational product. The reason being, if you have significant benefit shown on the investigational arm, it would be unethical to deny that benefit to the placebo patients - patients would at that failsafe point, be permitted to switch arms.

I'm making you a little cabled alpaca wrap - remembered you were always cold during your last tx cycle.

[wyndywyo]

I was hoping you'd have time to give that a read. It is so much more stringent than the others. The small sample group kinda puts on the pressure, but when you figure there are people all over the world participating at the same time, that's a pretty amazing sample! crikey!

The wrap sounds fantastic :) I was reviewing some notes from the first go-round with combo and have located all things warm and snuggly for the chills, and all things fibery for the, well, the other ongoing problem =p I also plan to stock up on Ensure since that was about the only thing I could hold down for a while.

Am trying to think positive - at least I can prepare somewhat, knowing a bit what to expect.