sis of the Clinical Research Enterprise that poses huge challenges in methodology and infrastructure. Researchers need to be properly trained in this new type of clinical research, or in research that answers slightly different questions. Some of this shift in emphasis is being driven unilaterally by purchasers and payers who are increasingly taking a more active role. The goal can be accomplished by the payer-purchaser community coming together and bringing its funds and resources to bear on this movement in a new direction. It can be best achieved, however, when all components of the enterprise cooperate with each other.

The research community must recognize that a move to this new type of research leads down a long, difficult road and marks a serious shift in the emphasis of the Clinical Research Enterprise that poses huge challenges in methodology and infrastructure.

—Sean Tunis



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