Lilly is not the only company exploring adaptive designs. Several of the industry's giants, not to mention obscure companies such as Asthmatx, are testing the approach. The concept is simple. At predetermined intervals, in a statistically rigorous manner, sponsors are peeking at early data from a trial to change the same trial before it ends. Perhaps 10 percent of device trials already use adaptive techniques. The lobbying group Pharmaceutical Research and Manufacturers Association (PhRMA) is putting out position papers to shape the debate, and European and U.S. regulators vocally support the idea. As a result, many in the industry are asking what they will need — and when they will be ready —  to execute adaptive designs. Vendors such as Cytel, Axio Research, Phoenix Data Systems, Almac Clinical Technologies, Tessella, and ClinPhone are stepping forward with software and services.

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