Similar regulatory clocks, divergent paths to study start

Regulatory review clocks are broadly similar across regions, but the paths to first patient are not. Speed reflects whether authorities meet, beat, or overrun those clocks; how regulatory and ethics reviews are coordinated; whether notification replaces formal review; and how quickly sites activate.

The fastest reported starts come from specialized pathways rather than general national systems. Dedicated early-phase units in Australia and Japan compress ethics review and site operations, while China’s investigator-initiated (IIT) pathway substitutes parallel institutional scientific and ethics review for an NMPA clinical trial application. The two- to three-month trial starts illustrate what purpose-built infrastructure can achieve, but they are not national averages...