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The State of Adaptive Clinical Trials
Industry Standard Research (ISR), Dec 2010, Pages: 78
With the February 2010 FDA guidance released on adaptive design trials, there has been no shortage of media coverage surrounding adaptive clinical trials. Combine this with the pharma industry's continued economic woes and the potential for adaptive designs to shorten the development time and lower development costs and the time seems ripe for adaptive designs to move up the traditional product/service adoption curve and leave the 'innovator' phase.
But inertia is a powerful force. Drug developers have been conducting clinical trials in basically the same manner for decades. Industries, companies, departments, and careers have been built on this model.
Adaptive trails will continue to pick up steam over the next two to five years and the companies that can both design and execute these trials have the potential to differentiate themselves in the marketplace and from their competitors, but only if they learn from those who have gone before them. This report provides insight and advice from people who have been down this road before and provides areas of potential growth and decline in adaptive design types and phases of clinical development.
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