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National spending on clinical trials was nearly $24 billion in 2005. By 2011 it will be $32.1 billion at a growth rate of 4.6%. At an AAGR of 5.8%, BCC predicts the number of clinical trials performed in 2011 will reach more than 13,000. Currently, most clinical research in the U.S. is subject to regulations like the Common Rule applying to research conducted or funded by Federal agencies, like NIH or U.S. FDA regulations, which apply to commercially sponsored clinical research related to the development, review, and approval of new drugs and medical devices. Between the 2 regulations, the Common Rule uses a system of assurances, while FDA regulations employ a compliance model that requires detailed documentation.

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