Oncology trials make up over a third of today’s pharmaceutical research pipeline, but conventional oncology drug development programs are often inefficient, expensive, and suffer from high failure rates. Of the oncology agents that enter Phase I trials, only about 3% eventually receive approval from the United States Food and Drug Administration (FDA).
Just as other industries have moved toward more flexible methodologies that foster continual improvement and operational efficiencies, clinical development is slowly ramping up adoption of innovative designs after being encouraged by regulatory agencies to speed progress, reduce inefficiencies, and improve success rates.
This article focuses on the early stage of oncology trials where important decisions about dose selection and target indications that may have far-reaching consequences are made. We explore potential scientific and operational implications for two different well-established designs:
- The continual reassessment method (CRM), an adaptive design that identifies the target dose
- Basket and umbrella trial designs, types of master protocols that may address multiple research questions under one protocol to identify target indications and patient populations