Clinical research in the US typically takes one of two routes: either "regulated," following the Food and Drug Administration (FDA) guidelines, or "unregulated," typically following those of the National Institutes of Health (NIH). In the UK, there is one pathway that involves application to the National Institute for Health Research (NIHR). What are the consequences of these systemic differences? How do researchers from both sides of the Atlantic fare with their respective systems? What strategies could be put into place to alleviate the strain created by complex procedures and general bureaucratic minutia inherent in working with regulating institutions?

Drs Harrington, Bhatt, and Cleland share their experiences and offer insight on how to support innovative research.