[paula_w]

The PD Pipeline project has posted the results of the survery about sham surgery at:

http://www.pdpipeline.org/whatsnew/shamsur_survey.htm

We are just about finished with a first draft of a PD trial participant Bill of Rights. There is increased interest in this area now. if you have an experience that you would like to share about a clinical trial, please post or contact the Pipeline Project at:

http://pdpipeline.org/aboutus/request.htm

Your input is valuable in choosing what goes on this document.

Thanks all,
Paula

[indigogo]

I think this is a really important topic (clinical trials).

There is a group of people, including, at least, on this forum Paula and JeanB, who have been working hard to craft a document that will protect the rights of patients in clinical trials, and thus, hopefully, make the prospect of joining one more palatable.

It is a complicated issue. Take "risk" for example. It is a concept without one, single meaning. Maybe people with a life-threatening disease would like to be able to accept more risk when entering a trial. How does the system balance risk? Can they make a completely risk free trial? Should they? How do we make sure that participants actually understand the risk they are taking? (i.e. the woman who just died from the gene therapy treatment - did she really understand the risk? if she did, would she have signed on? would a person whose life was at stake be willing, and be allowed, to take more risk?)

JeanB makes a wonderful point in her thread about her experiences as a participant in clinical trials, that "It's easy to talk about the problem. It's harder to be part of the solution."

Being part of the solution does not necessarily mean signing up right now for a clinical trial. It also means helping to make the system better for patients so that more trials can go forward more quickly - and maybe making you feel more at ease in joining a trial yourselves.

If you don't feel comfortable joining a trial, or even if you do, please think about participating in the process by letting your views be known by giving your input at

http://pdpipeline.org/aboutus/request.htm

Thanks to Paula, JeanB, Carolyn, and anyone else who are using their time, talents, and bodies to advance our cause!

[paula_w]

Thanks, nice post Carey. When we start out thinking about clinical trials, we think mostly about whether or not the treatment will work or will it help me. But two of the deaths that we have recently heard about (each involved brain surgery but not the same trial) were caused from complications from falls.

This allows the sponsor to claim the death was not their responsibility and to not honor their commitment to cover medical care.

Falling is one of the top reasons for all pwp deaths. Brain surgery may make this a very high risk - higher than it already is. Hospital staff must be made aware of this and the Informed Consent must include it.

We want to be sure and include every valid thing we hear about, thus the request above. If you are in a trial involving brain surgery....has it affected your balance?

paula

[Stitcher]

Originally Posted by indigogo

There is a group of people, including, at least, on this forum Paula and JeanB, who have been working hard to craft a document that will protect the rights of patients in clinical trials, and thus, hopefully, make the prospect of joining one more palatable.

Yes, there are about six of us who are working on this document, along with the assistance of PDF. One of these days when it is done we should be able to share it with the community...at the least, it WILL be posted on the PPP website and the URL link to the document will be shared here in NT and ListSrv.

Paula said: Falling is one of the top reasons for all pwp deaths. Brain surgery may make this a very high risk - higher than it already is. Hospital staff must be made aware of this and the Informed Consent must include it.

We want to be sure and include every valid thing we hear about, thus the request above. If you are in a trial involving brain surgery....has it affected your balance?

We have racked out brains to ensure that everything we can think of is in this document.

If you have had an incident or concern about a trial you were involved in, now is the time to voice that concern. My recent CERE-120 trial has been a big part of what the documents contains.

GO CLINICAL TRIALS...but with care and dudiligence by all patients!