Thanks so much for joining in and your question [if i had been holding a pencil, i would have put it down!] is almost so simple it's hard to believe something like that could be overlooked. We have been puzzled by the wording of this announcement all along.
In your first post, another interesting thought:
"Putting placebo patients through great emotional and physical trauma and taking every precaution to make the experience feel as real as possible does one thing to a clinical trial - it corrupts the results by producing an abnormally powerful placebo response."
This might be especially true with sham surgery.
Talking about your son brings the story home to all of us. So many other people are stressing right along with us.
I will ask you the same question as Dottie. If they go to phase III, are you entitled to the treatment? Does the Informed Consent address this?
paula
Quote:
Originally Posted by Tom819
The Results:
The trial did not demonstrate an appreciable difference between patients treated with CERE-120 versus those in the control group. Both groups showed an approximate 7 point improvement in the protocol-defined primary endpoint (Unified Parkinson's Disease Rating Scale- motor off score at 12 months), relative to a mean at baseline of approximately 39 points. Both groups had a substantial number of patients who demonstrated a meaningful clinical improvement from baseline. CERE-120 appeared to be safe and well tolerated.
Now I am awake (look out everyone!!!). After these results were announced, I was stunned. Ceregene is a very impressive company. They did an amazing job meeting the timelines promised and I have a tremendous deal of respect and gratitude for their desire to find an effective treatment so this is not a "sour grapes" comment. It is extremely important that everyone stop what they are doing, put their pencils down and hear this:
If Patient #1 in the real treatment group reduced their meds in a dramatic fashion and demonstrated a 7 point improvement and Patient #1 in the placebo group demonstrated the same 7 point improvement but increased their meds (which was permitted as long as the sponsor was notified in advance) how is this considered the same result? Please tell me the results were weighted in some way to account for this. If not, then a major injustice has occurred here!!!
|