"Technology is the great enabler of process change," said Gottlieb, according to the transcript of his speech, released by the FDA. Tools such as toxicogenomic assays can provide important information about a drug's effectiveness and safety. An adaptive trial would generate and incorporate such information to help guide the more effective use of medicines. In an adaptive trial, for example, patient outcomes could be used as they became available to adjust the allocation of future patients or some other aspect of the study design.  

Recognizing trepidation on the part of some in industry, Gottlieb described new steps the FDA is taking to encourage the use of adaptive designs. "Sponsors need consensus and clarification on pivotal scientific questions related to when adaptive trial design is most appropriate," said Gottlieb, citing the need for sponsors and the FDA to work together.  

Toward that end, FDA leadership is working on a series of guidance documents that will help articulate the pathway for developing adaptive approaches to clinical trials. The one likely to be presented first, perhaps as soon as January 2007, will help guide sponsors on how to look at multiple endpoints in the same trial.  

Gottlieb stated the FDA is open to new scientific advances in clinical trial design that enable the agency to learn more about how to safely guide clinical decisions, and requested help from the broader community, including patients and product developers. If information that helps predict response can be better adapted into the trials themselves, the results will be clinical development programs that better guide treatment decisions. Said Gottlieb, "It will enable the day when we are able to reliably deliver the right drug in the right dose to the right patient." FDA