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By many measures, the US has the preeminent health care system in the world and will continue to be a leading region for conducting clinical trials. The Food and Drug Administration (FDA), hospitals, and physicians in the US have set the standard with regards to clinical research and patient care.
The FDA has traditionally required the patient populations for clinical trials to represent the heterogeneity of the US population.
Investigators in the US are among the most experienced in the world. The scope of their training and education is well respected throughout the world.
Even with increasing competition, the numerous medical centers and research sites throughout the US allow sponsors to recruit patients.
A vast majority of clinical research centers employ dedicated study coordinators who focus solely on clinical research to facilitate timely regulatory approvals, patient recruitment, and data collection.
Given that central institutional review boards (IRBs) and dedicated research centers allow for faster start-up timelines, sites in the US are typically the first to enroll patients in global clinical trials.
Investigators in the US are well trained to appropriately address considerations unique to pediatric research such as informed consent/assent and challenges associated with pediatric enrollment. In addition, the US has more experience conducting pediatric clinical trials than any other country.
The US remains the key market and profit center for the pharmaceutical industry. It is strategically important for investigators to have experience with a new drug prior to registration and for sponsors to build lasting relationships with those who will ultimately prescribe them.
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