Two Questions re PROVE 3

[ChrisDDD]

Question No. 1:  Does anyone know how many people who want to get into PROVE 3 actually get in and how many don't?

Question No. 2:  Does anyone know how many people get screened for PROVE 3 and are accepted versus how many get screened and are rejected?

Thanks.

[APKhaos]

These answers may be unknowable.

Question No. 1: Does anyone know how many people who want to get into PROVE 3 actually get in and how many don't?

>> The lists of applicants are distributed accross each participating clinic, and the decision to accept an applicant is local. Not sure if this data is actually collected at the clinic level, let alone rolled up to the top.

Question No. 2: Does anyone know how many people get screened for PROVE 3 and are accepted versus how many get screened and are rejected?

>> Once again, its all at the clinic level.

Thanks.

[ChrisDDD]

It would be interesting to know these numbers and the reasons for acceptance versus rejection to determine one's likelihood of being accepted, in addition to determining if one is being discriminated against for any particular reason, and also to determine the rigidity or flexibility of various hospitals regarding clinical trial applicants and whether they vary by region or country.

[susan400]

I asked the study nurse, specifically today if this was the same answer that I would receive at all trial sites for Vertex, or if it was just their clinic.  She adamently told me that their clinic (Jacksonville location) went to bat for me, trying to fight for me to get in with the records I had.  She said that she called the Duke rep and pled my case.  No dice.  So, I don't know what to think about that.

Susan

[jboyhk]

I understand your frustration and feel for you.

But you have to look at it from Vertex's point of view. They want the FDA to approve this drug so all can use in the future.
Therefore, since they are 'oversubscribed' with potential candidates, they will pick the ones that have the least issues.

At this point, sorry to say, their concern is not treating individual patients, but getting ceritfication to treat the masses.

I wonder if contacting the FDA directly and telling them of your situation will allow your own dr to prescrible VX-950.

[chcnme]

hmmm... Well then - on Duke (or calling them)?  I'd say not to spend too much time trying to call them on the VX unless you just want to hear what they might have to say or the explanation they might give   (and if they give you an answer it will be very short).    McHutchison is the main doc on the VX  and ... well - if your doc in Jville told you they went to bat and really really tried for you (and I'm sure they did)  then you probably won't get anymore info from Duke, sorry to say.  

What JkBoy said -- the off label (or whatever the term is they use before a drug it's approved and when it's sometimes prescribed for certain groups before it's "FDA approved")   might indeed be a good thing for you to inquire about on the VX.   GOod luck.

[ChrisDDD]

Well, this is what I keep hearing, doctors fighting for their patients to get into the VX-950 trials.  As I'd said earlier, my second-opinion doctor at Beth-Israel said he would fight for me to get into PROVE 3 with all he had, and I'd said at the time, fight who?  As the study doc, he makes the decision, and he never gave Vertex's safety coordinatory the opportunity to exclude me.  He did that all by himself.

I'll think about the FDA thing and see about getting it prescribed, but I doubt it will work.  Great idea, though!  And I do understand this is for the "greater good".  I don't want to be the one that causes a stumble in Vertex's statistics and delays the FDA approval of Telaprevier so that we can all have it.  It's just that only today by listening to the Vertex webcast from Barcelona did I find out that they had ANY non-compliance or drop-outs and that they did expect some adverse events.  My understanding from research and from my docs is that my AE's are common and not unexpected, and more than compensated for by my willingness to comply with Vertex's requirements.

I'm delighted for those who get into the trials and appreciate also their willingness, while at the same time I must admit some envy in ther opportunity to cure and put this behind them.  I feel my disease is progressing in that several blood test numbers are falling into the abnormal range in the last year, where for years it's only been the the AST and ALT that were abnormal.  Also having intermittent symptoms.  Creepy.  I should walk away from this and forget about it, but it's not so easy anymore as the fatigue really is overhwelming.  When grappling with that on a daily basis, together with other symptoms, it's not so easy to forget.  Thanks for your help.