There are many merits to conducting clinical trials in the US. The country, after all, represents the largest market for pharmaceuticals in the world, generating roughly 50% of global prescription drug sales. Data from trials conducted in the US generally face fewer hurdles with the US Food and Drug Administration during reviews, and a multi-ethnic population helps diversify the demographic pool.
So why did nearly a quarter of the 37 surveyed early-stage biotechs not pick the US as their preference for first-in-human trials? Let’s dig in.
Clinical Holds
A recent survey by the Biotech Consortium to Accelerate Innovation (BCAI), in partnership with MassBio, showed that while a majority of surveyed companies picked the US for first-in-human studies for drugs in rare and serious diseases, it was only when FDA review criteria are consistent. Australia emerged as the other desirable pick.
The main reason, according to 73% of those surveyed, is delays and financial costs related to FDA clinical holds and revisions. Executives also said that current turmoil at the agency and high turnover among employees were problems, with 54% of respondents saying they would be less likely to test new drugs in the US.