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Old 02-18-2009, 10:44 AM
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jeanb jeanb is offline
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Join Date: Aug 2006
Location: sonoran desert
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15 yr Member
jeanb jeanb is offline
Senior Member
jeanb's Avatar
 
Join Date: Aug 2006
Location: sonoran desert
Posts: 1,352
15 yr Member
Book Fda

First- thank you, Debi for responding.

To my understanding - the FDA allows sham surgery but it doesn't have an official policy where it recommends the procedure for trials.

Since DBS surgery went through trials without using sham surgery, i still don't understand why current gene therapy trials insist upon sham surgery.

Even though I am an outspoken advocate in support of clinical trials, and I have already participated in 4 trials, I will not join a trial where sham surgery is part of the protocol.
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This isn't the life I wished for, but it is the life I have. So I'm doing my best.
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