NeuroTalk Support Groups - View Single Post - Cere 120

paula_w · 01-31-2009, 10:48 PM

This issue must be addressed. I think we can do it, I sent almost all of this out to some groups already by email, not to agitate [I would just admit it if I was] but to...oh fill in the blank. There are many reasons - it's one of the main things. People with emotions are the reason we are all unpredictable - our mind/body connection separates us from animals [ at least in some pretty important ways] and money.

Sent last night:

After writing and being published with questions about trial protocols and sham surgery emphasized as being questionably ethical for the last several years, it seems that we are in the middle of what you could call an application phase. MJFF did the Bartus interview, which answered many of our questions, tackled the hard issues, and risked future business or interest in cere 120. It sounded honest, but now also seems like the most opportune moment to pull out the Declaration [formerly Bill of Rights] and see how their performance compares to our expectations, particularly regarding the sham surgery participants getting the treatment. Hopefully, both sides are listening.

This was a first that I know of- this interview - and I think it was a result of a lot of squawking on our part, along with a lot of hard work from all stakeholders - everyone. MJFF came thru with the info, and did it immediately..after funding it quickly. We were watchdogging right there all along as well. So let's take a look. Where is the latest copy of the Declaration and checklists? Is it all on the pipeline site?

Here's some information that could help. The full interview, a must read, is here: it is outstanding - the pd community has come a long way since GDNF.

http://www.michaeljfox.org/research_viewpoints_newsInContext_article.cfm?ID=1 1

Below are some very important comments.

Ray Bartus comment regarding those who received sham surgery about 'what's next'?

MJFF: If you launch a second CERE-120 trial, will you be able to re-enroll the trial participants who received sham treatment in the first study?

RB: I actually raised that issue and discussed it with my colleagues. Wouldn’t that be a great thing to do? You have these patients who were courageous enough to volunteer for this study, but they got sham treatment, so wouldn’t they, therefore, be great candidates? From a humanistic standpoint it would be a great thing to do. But from a scientific standpoint, you quickly realize that you would really compromise the program by going in that direction.

First of all, the patients have now progressed another year or two from where they started with our trial. There is a very general consensus, based on some data and a lot of intuition, that the more the disease progresses, the less benefit one might expect from CERE-120. Thus, using these patients for an important ‘go/no-go’ decision could represent a serious mistake if the dosing change indeed worked but we did not see a strong effect because of their disease progression.

Secondly, 70 percent of those patients have already showed a robust response — that is, a placebo response. If they already have an elevated baseline, we could be shooting ourselves in the foot trying to overcome that. You see how complicated it gets.

From two sham surgery participants:
Dottie
From Informed Consent:

If it is determined at the conclusion of this study that it is appropriate to provide CERE-120 to people with Parkinson's disease, those assigned to the sham surgery group may be permitted to enroll into an open-label follow-up study in which CERE-120 will be given"

The Questionnaire has this:

After the study is completed, you will be informed about which group (active treatment with Cere- 120 or sham surgery) you were assigned. If you were assigned to the sham surgery group, are you aware that you will have the option to receive active treatment with CERE-120? Yes/No

I [Dottie] sent the coordinator the following:
" Someone asked me about the option of having the surgery - did that end with the completion of phase 2 or does it carry over to phase ?

Her [coordtinator] reply:
"...I have not heard anything regarding a possible phase 3. I was told the last time I inquired that they were still in discussions as to what and if there would be a next step even with the sham group".

This is not complete or conclusive information. Dottie is still checking.

Tom819
From the consent form:

"If results confirm the continued safety and efficacy of CERE-120 following the conclusion of the trial, another study will be opened to allow subjects who received the sham surgery to receive the study drug CERE-120. Participation will be made available to all subjects deemed suitable for the surgical procedure by the subjects study neurologist and neurosurgeon."9

Perhaps none of the sham surgery participants will want the treatment now. But the question does need to be addressed if a Declaration is ever going to have meaning don't you think?

I think the interview is awesome and historic as clinical trials go, can we carry it through? The placebo and mind trickery really are a problem all around. I appreciate that everyone is trying to solve it and the speed at which it has been moving is as refreshing as a windy day in Florida.

Declaration of Rights and Resp. written by pd Pipeline Project and other pwp, along with PDF

Copy of corresponding expectations are largely in this section.

Clinical trial participants with Parkinson's disease have the right to post-study information and options for care including:

Trial results.

Information about the conditions which they may receive post-trial access to the experimental treatment.

Notification as to whether they received a placebo or the experimental treatment and at what dosage.

The option for participants in the experimental/treatment group to continue the treatment. Likewise, those who received placebo or low dose treatments, or sham surgery should have the option of receiving the experimental treatment at the full dose, upon conclusion of their trial.

Results of all tests and procedures and copies of scans, x-rays, MRI’s, etc. if requested by the participant.

Updates about all adverse events following trial conclusion.

http://www.pdpipeline.org/advocacy/rights.htm

paula

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