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08-22-2008, 08:00 AM | #1 | |||
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Magnate
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I posted this to the Clincial Trials subsection, but not to this part of the board. I am moving this to the primary board so that Perry's comments can be seen.
Below are comments from Perry Cohen about Sham Surgery. Any replies to his comments? Quote:
These are a few of my questions to the FDA and the company based on our pipeliner experiences with many clinical trials. We have asked FDA to consider participation in a round table discussion on the issues around sham surgery, The question in this case is what is the value of the data gained by a burr hole and exposure to anesthesia as designed to trick the patients into uncertainty about whether they got the treatment. On the face of it, to me this design would undermine the therapeutic impact for those who got the treatment as well. In order to think through the logic of the designs carefully, we need to hold this workshop as soon as possible, with FDA and scientists. I expect that PDF will sponsor the meeting this fall. In meantime I would like to hear responses from PWP who are eligible for this study what factors they consider important in entering this clinical trial. Lets get the discussion started to find out how PWP perceive the risks and benefits, to let them know how we and other PWP feel. Then we can either endorse the practice or condemn it. If we do nothing they will continue to ask for this risk to be taken on by volunteers desperate for relief. Perry
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You're alive. Do something. The directive in life, the moral imperative was so uncomplicated. It could be expressed in single words, not complete sentences. It sounded like this: Look. Listen. Choose. Act. ~~Barbara Hall I long to accomplish a great and noble tasks, but it is my chief duty to accomplish humble tasks as though they were great and noble. The world is moved along, not only by the mighty shoves of its heroes, but also by the aggregate of the tiny pushes of each honest worker. ~~Helen Keller |
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