Over the past two decades, the decision process for sitting overseas clinical trials has become more complex for U.S. pharmaceutical companies. Once a straightforward analysis rooted in time and money, longer-term strategic issues are now pushing to the fore, combining to make these high-investment, high-risk calls even more multifaceted.
These challenges become particularly focused for small pharmaceutical and biotechnology companies with time and resource constraints. There is also a need for smaller companies to lay the groundwork for rapid adoption of their approved product,particularly with diseases unique to certain populations or regions. In those situations, a “hearts and minds” effort with local hospitals and doctors can build a comfort level for rapid use of the drug. Orphan drugs targeting smaller populations can live or die commercially by missteps in the human aspect of the trials conducted in the target geographic populations...poisoning the well, as it were.