who we cannot even imagine at this point, who might make use of the data?” said Loder.

Loder also called attention to the need to build trust in the clinical research enterprise. This trust is at “an all-time low,” she said, which is causing a crisis in recruitment for clinical trials (Williams et al., 2008).

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FIGURE 2-1 A “cycle of quality” from discovery science to the measurement of outcomes can generate evidence to inform policy.
SOURCE: Califf et al., 2007.

BOX 2-2
Treatment Advances for Cardiovascular Disease: A Success Story for Data Sharing

The risk of death after a heart attack is now 40 percent lower than it was before the development of medical therapies designed to reduce such deaths (Krumholz et al., 2009) and the development of these therapies relied extensively on clinical trials, said Rob Califf, director of the Duke Translational Medicine Institute, professor of



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