Balancing speed, science and regulatory requirements in oncology drug development. Correspondence from Alexandra Snyder generate_biomed, PritiHegde Foundation Medicine, and colleagues
— Despite continuous advancement over recent decades, effective therapies for advanced cancer are urgently needed. The development of such therapies increasingly occurs in the setting of small biotechnology companies. In biotech, market financing has historically fueled innovation, with demonstration of proof of concept in the clinic driving increased value.
Although this system has led to innovation, the practice of hypothesis testing in early oncology phase 1 studies of drug candidates creates uncertainty and heightened volatility, which risks hampering innovation. Project Optimus, a recent US Food and Drug Administration program, has intensified the focus on randomized dose-finding in early drug-development trials.
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