[paula_w]

New Survey on SHAM SURGERY in Parkinson’s clinical research.
What do you think?

As more Parkinson's treatments involving surgery , (such as gene therapies ) move into phase II and III clinical trials, we can expect increased use of sham surgery as the placebo control in clinical trial designs.
This means there will be a control group of randomly selected trial participants who will be surgically prepped, be placed on IV solutions, undergo anesthesia and have burr holes drilled into their skulls and possibly enter into brain tissue , but they will not receive the experimental therapy. They may also receive immunosuppressants and/or antibiotics following the sham surgery. All surgical procedures and possible risks must be explained to and agreed to by the patient as part of the informed consent process. These trials are usually double-blinded – neither the patient nor the trial staff, except for the neurosurgeon knows if they received treatment or a sham procedure.
Alternative trial designs are being developed, but are not yet widely accepted by the consensus of scientists and the FDA.


In 2007, the Parkinson Pipeline Project (PPP) conducted an informal survey of PWPs views on sham surgery. We are now conducting an updated survey.
On June 30-July 1, 2010 the NIH will be conducting A 2 DAY WORKSHOP on
“ Sham Neurosurgical Procedures in Clinical Trials for Neurodegenerative Diseases:
Scientific and Ethical Considerations “. The PPP will be submitting the results of this survey to the OBA, organizer of the workshop.

PLEASE participate ! Just copy this survey, enter your responses and email it offline to: Ljherman1@juno.com .
E-Mail by Friday, June 4, 2010

Survey of PWP on Sham Surgery in Parkinson’s Clinical Research (2010 update)
Some questions will be asked twice. Answer the first in regard to sham surgery that involves drilling into the skull, but does not penetrate any brain tissue. Answer the second in regard to sham surgery the involves drilling into the skull and penetrating the brain tissue (e.g. inserting a brain catheter; needle passes through the brain, implanting a delivery device, such as a pump, etc)

The Survey Questions
1.Before taking this survey, did you know that some clinical trials use sham surgery as a placebo control? (Y or N)


2.Is the scientific information gained by clinical trials worth any risk to trial participants who receive sham surgery (burr holes drilled into the skull only ) ? (Y or N)



3.Is the scientific information gained by clinical trials worth any risk to trial participants who receive sham surgery (burr holes drilled into the skull and brain tissue penetrated? (Y or N)

4.Would you volunteer for a trial knowing you could receive sham brain surgery in which your skull would be drilled into? (Y or N)

5.Would you volunteer for a trial knowing you could receive sham brain surgery in which your skull would be drilled into and your brain tissue penetrated? (Y or N)

6.Are there any guarantees from scientists and trial sponsors that would make the risk acceptable to you?



7.Do you have any other comments?



QUESTIONS 8 -12 ARE OPTIONAL
8.What country are you a citizen of?

9.Have you ever participated in a medical clinical trial? – In a surgical clinical trial?


10.What is your age?


11.What is your gender?


12.How many years since your diagnosis?

END of SURVEY
PLEASE copy this survey, enter your responses and email it offline to: Ljherman1@juno.com
by June 4, 2010.
After the ending date, the results of this survey, along with the 2007 survey will be posted on the PPP website ( www.pdpipeline.org)

[paula_w]

google search for information on sham and placebo

http://scholar.google.com/scholar?hl...=2010&as_vis=1

[pegleg]

here is a link to the workshop website:

http://oba.od.nih.gov/rdna_rac/rac_sham_con.html

peg

[GregD]

is this a new survey or has it been out for awhile???? I remember taking a survey like this already.

GregD

[paula_w]

Originally Posted by GregD

is this a new survey or has it been out for awhile???? I remember taking a survey like this already.

GregD

... you remember correctly. See above:

In 2007, the Parkinson Pipeline Project (PPP) conducted an informal survey of PWPs views on sham surgery. We are now conducting an updated survey.

[olsen]

Here is a burning question I have in regards to this topic: what do other countries do in reference to "sham neurosurgical procedures" in clinical trials? madelyn

[paula_w]

I'll look into it because we need to try to redefine much of the new pd picture

very good question madelyn! I'll look responsibly for replies to your questions.
or anyone jump in and teach us.

Originally Posted by olsen

Here is a burning question I have in regards to this topic: what do other countries do in reference to "sham neurosurgical procedures" in clinical trials? madelyn

[jeanb]

Originally Posted by olsen

Here is a burning question I have in regards to this topic: what do other countries do in reference to "sham neurosurgical procedures" in clinical trials? madelyn

I'm curious as well - are they doing sham surgery for PD in Europe? Or in any other countries for that matter? And if they don't, what methods in lieu of sham surgery are used?

Jean

[paula_w]

in many other countries. I don't know who else does do it so if anyone is inclined to help with some fact verification.... this info very useful.

[made it up]

Hi Paula and Jean,

I'm fairly certain as far as neurosurgery for PD goes sham surgery hasn't been performed here.

Might be wrong but I think the same goes for any other type of surgery too.

Lee