Posts tagged adaptive designs.
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3 minute read
Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available about a drug’s safety and benefits. The two draft guidances address, respectively, adaptive designs and master protocols. This blog post discusses FDA’s recommendations for adaptive designs; master protocols will be addressed in a subsequent blog post.
An adaptive design is a “clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on the accumulating data from ...
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