|
 |
|
|
By many measures, the United States 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 United States 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 United States population.
Investigators in the United States 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 United States 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 United States are typically the first to enroll patients in global clinical trials.
Investigators in the United States 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 United States has more experience conducting pediatric clinical trials than any other country.
The United States 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.
|
|
 |
|