drivers of standards and that scope of practice is
primarily influenced by institutional policy and state
regulations of nursing practice, which vary widely.
There is no denying the fact that clinical research
has become a global enterprise. This has been driven in
part by the escalating cost of bringing new drugs and
treatments to market combined with investments
in technology and clinical research infrastructure
in rapidly developing countries such as China and
India.84,85 At the end of the 20th century, there was
a growing understanding that the development and
distribution of new pharmaceuticals and devices was
a rapidly growing industry, generating its own financial,
ethical, and political growing pains.86 Globalization
of the drug and device development industry has
increased dramatically since then, with the US,
Canada, the UK, and Europe still holding the lead in
terms of absolute volume of trials and participants, but
with the greatest growth being seen in the developing
countries of Asia87 and, more recently, South America.