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Page 3 Page 1 - 2 - 4 - 5 - 6 - 7 - 8 - 9 - 10 - 11 - 12 - 13 Well, actually it's worse than that because instead of this continuous flow of experiments, the most important neurologically significant experiments come in big, big batches. Instead of FedEx trucks, it’s like a train that leaves the station once a decade, and you better put your experiments on that train because if it leaves the station, you may have a better idea that will have to sit around and wait for the next decade or the next train. Example -- one of the trains that had left is a NIH/NINDS-driven clinical trial to establish neuroprotective characteristics of a variety of agents. The train will take seven years to go to its destination. The estimated cost is $60 million. That's bad enough, but the evaluation methods that are on the train are even more concerning.
The train experiments start by eliminating those candidates that don't make the cut line. These are called futility trials. The drug is considered non-futile, in other words, worthy of further travel, if it provides a 30 percent improvement. At this point you should ask, "Improvement as compared to what?" and I would say, "I'm glad you asked that question." In comparison to prior clinical trials placebo arms.
Net-PD train does not have its own placebo. It relies on old trials’ placebo arms. Placebo is placebo. One placebo is as good as another placebo. Well, that was what I call a hidden assumption, an assumption that should be stated as an assumption but isn't. Hidden assumptions lead to danger. An illustration:
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Copyright © 2004-2009 Parkinson Pipeline Project. All rights reserved. Revised: 03/30/09. |