Loosening the reins: The bold risks required to overhaul first-in-human trials

There’s no way back on first-in-human trials. Unasked and uninvited, China has changed the global narrative on delivering early human clinical data, with a new bar for speed and efficiency. Drug developers and policymakers globally have read the signs and know that this is not a time for complacency. Competition has done its job.

The U.S., as the de facto global leader in biopharma, has both the biggest influence and highest stakes. But it is by no means the only region involved in this global race. Rather, Europe — in particular some EU member states — the U.K. and South Korea see this moment as a chance to refashion their place in the global order of biotech hubs. Fix their early clinical enterprise, draw more biotechs to their shores, and the rest will follow, goes the thinking...