Invited to 2 more trials

I was asked to participate in 2 more trials.Can someone please look at them for me and decipher?They are NCT 01271790 & NCT01225380. Im a dumb bunny when it comes to these things.  thx  cindy

[Bill1954]

For comparison sake what other study drug are you considering, Cindy; without getting into the nuts and bolts of these studies, are you aware they are both phase 2b trials?

Bill

[EyesofBlue55]

oops !!! Not for me I dont k now how to read these things.I told you I was a dumb bunny!!!LOL

[Bill1954]

Cindy, I’m not necessarily trying to discourage you; I’m just pointing out that they’ll have less clinical experience with these than say, a phase 3 product.

http://en.wikipedia.org/wiki/Clinical_trial#Phase_II


“Phase II

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects…”


“Phase III
Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions…”

--Bill

[Bill1954]

If you’re a dumb bunny, you’ll be an incredibly well-researched and informed one by the time this is all over, Cindy :o). If you like, someone will review those studies with you. It’s a bit time consuming, and I (or someone else) didn’t want to spend time reviewing something you wouldn’t be interested in, that’s why I pointed that out. It was a good place to begin asking questions.

-Bill

[shaaaaaaaa]

Ask your doc. Seriously, every thing is just us giving an opinion. None of us are doctors (although we all stayed at a Holiday Inn Express last night).  ;)

Deb

Bill is the most helpful guy here......he's telling the truth.

"Holds you in his armchair
you can  feel his disease
Come Together
Right now, over me"

[blondie717]

  Learn anything new yet???? I could only find one of as per conversation..The way I see it is a 3 arm  = the same odd's I had and same phase as mine, and your a cc Il28B...my odds were only 66.6%...I like what fretboard had to say to Mary4Now in her trial. I think you should talk to her some about it see what she learned..Look @ her post and although I could not talk to my GI about any trials you can talk to yours..I like the Idea of being und by day 28.... I think most people need to TX as soon as possible in this economy..Today we have health insurance , but who can say about tomorrow? Last month I spoke w/someone I had not spoken to in 30 yrs, and everything was glorious w/the company. This month peoples hrs been cut and away with their health insurance... I sure am glad I opted clinical trial. I was hoping to use my bl/cr blu/shield of that failed...And I just found out it was canceled 12/01/10.... I think you should follow your gut once you have all the information , you discovered...

[Trish77]

Cindy, it's good to get practice reading trial documents.  I'd give it a go and see what you come up with - post what you think you're reading and then ask for feedback.

I'd start with looking at the arms - how many are there?  The more arms, the more the variables.

Then look at the dosages.  Are there any where you will not get SOC?  

How many arms have the trial drug?  All of them but the control arm?

Depending on how many arms, what are your chances of getting the trial drug?  2 out of 3?  5 out of 6?

Will they shorten treatment if you have an RVR?  Are you okay with that if it happens to you?

How many weeks will you get the trial drug in each arm?

Then research the trial drug and see what the results were in the previous trials and when trial participants went SVR, what the side effects were, etc.

That's a start.  If you begin to get really serious - then there are other things to consider such as if the trial allows rescue drugs and at what point the trial forces dosage reductions, etc. but those questions and others are for when you are seriously evaluating a particular trial.

Hope that helps some along with Bill's explanation of the difference between phases of a trial.

Trish