The days when oncology drugs advanced foreseeably from Phase I to Phase II to Phase III clinical trials, with predictable pauses for regulatory reviews and refinement of trial designs, are gone.
A new, maverick model of seamless drug development is emerging, one in which a first-in-human trial can morph, without pause, into a pivotal efficacy trial. Due to competitive pressures, companies may need to change the way they develop oncology drugs, fast.
While seizing opportunities for efficiency and smarter advancement decisions, companies need to limit their exposure to safety and other risks. At PAREXEL, we advise companies to follow five risk-mitigation strategies to produce data-rich trials, better teamwork and more regulatory interaction.