FDA embraces seamless trial design — no more 'business as usual,' says agency chief

US FDA Commissioner Scott Gottlieb says he supports the use of seamless trial design, a game-changing approach to drug development that does away with the long-standing three-phase standard of clinical testing.

Speaking at the RAPS 2017 Regulatory Convergence Conference in Washington DC, Dr Gottlieb said: “These methods are increasingly prominent in oncology drug programs. Under the leadership of Rick Pazdur, our oncology center of excellence is taking steps to better evaluate and cultivate these new approaches.”

Noting that there are more than 40 oncology programs entering the regulatory process at the FDA that use this approach, Dr Gottlieb said: "Seamless designs are particularly advantageous for drugs that work in a variety of diseases, allowing rapid evaluation of the drug and potential approval under our accelerated approval pathway.”