In this special series, we aimed to include a wide perspective from regulators, bioethicists, statisticians, and clinician-scientists on the drug development continuum, focusing on challenges raised by new classes of therapies: immunotherapy, targeted agents, and cellular therapy. The review articles discuss the challenges raised by dose optimization in the phase I setting, and the ethics of early-phase trials that file for US Food and Drug Administration (FDA) expedited programs such as accelerated approval or breakthrough therapy designation. The series also includes reviews discussing efficient designs, such as basket trials, to assess efficacy in the setting of targeted agents, and window-of-opportunity studies that use the time gap before cancer resection to evaluate pharmacodynamic and pharmacokinetic signals of novel agents. Finally, there are review articles covering the methodologic challenges of later-phase trials, such as testing treatment effects in randomized studies where the benefit of therapy might not be constant over time, and how additional patient-level data can be used to generalize the treatment benefit of randomized trials to a broader population. These articles outline areas for future research and provide insight into the dynamically changing field of oncology drug development.
Devlin S、Iasonos A
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Memorial Sloan Kettering Cancer Center, New York, NY, United States
NSTL
Lippincott Williams & Wilkins
