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Seaside STX209

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With Seaside and STX209 in Our Rearview Mirror, What’s Next?

By |2013-10-10T17:40:08-04:00Oct 10, 2013|Advocacy, Advocacy Day, Seaside STX209|

The official result of the Seaside trials was that STX209 did not do what its makers thought it would. The present structure of FDA trials requires that the proponents of a new drug predict what it will do and then conduct trials to determine whether the drug delivers the predicted results. If it does not, that particular trial is deemed a failure and cannot be relied upon to make the case for formal approval of the drug.

Dr. Elizabeth Berry-Kravis on the Challenges Inherent in a Clinical Trial

By |2013-06-10T12:19:36-04:00Jun 10, 2013|Keeping You Informed, Seaside STX209|

When a lab experiment is being done for the first time it often has to be done six or more times before everything is finally correct and it finally works reproducibly. That’s distressing and frustrating, but this is actually more the rule than the exception. For a clinical trial the stakes are so much higher. It's not just distressing and frustrating for the researchers, but it also causes real disruption and agony in the lives of real people who are a part of these trials. So when we don't "get it right" the first time everyone suffers.