Principles and Practice of Pharmaceutical Medicine

entails keeping metrics of on time completion of
patient recruitment and enrollment, retention rates
of study volunteers, success rates with different
kinds of patient recruitment media and numbers of
studies completed in various therapeutic areas.
Sponsors looking to select sites for clinical trials
can use these metrics to distinguish performing
sites from nonperformers. In addition, sponsors
are increasingly using metrics to identify sites
with a higher probability of achieving trial objec-
tives on time (Anderson, 2004).
By reaching objectives, sites begin to form rela-
tionships with sponsors who recognize and
appreciate the contribution they make to the clin-
ical development of investigational compounds
and devices.

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3%

7%

8%

11%

37%

F alsif ying data

Poor AE reporting

Poor drug accountability

Inf ormed consent noncompliance

Protocol violations

Figure 11.9 Top five deficiencies (2004) [Source:Thomson CenterWatch, FDA CDER, 2004]

REFERENCES 137