Consideration of the Root Causes in Candidate Attrition During Oncology Drug Development.

Cancer remained the second-leading cause of death in the United States in 2020, based on the data from the US Centers for Disease Control and Prevention. The study for the success rate from first-in-human trials to registration for 10 big pharmaceutical companies in the United States and Europe indicated that the average success rate in all therapeutic fields was about 11% from 1991 to 2000. The success rates varied between different therapeutic areas, whereas oncology drugs had a relatively low success rate, approximately 5%.

Recent paradigm shifts in early-stage development and clinical development plans suggest that candidate selection is less influenced by toxicity reduction with more emphasis placed on biologic activity aligned with efficacy expectations. It may suggest that even when the oncology drug candidates had low safety concerns, a lack of efficacy may still be present and impactful. Underlying many of the issues is a necessity to better integrate and exploit data in addition to design and plan new and innovative clinical trials.

The capabilities of the Aridhia DRE align with both of these necessities and we are always promoting such solutions and use cases with the ultimate goal of accelerating the availability of new medicines to the patient populations that need them.

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