White Paper

Advancing Early Phase Oncology Trials In The Era Of Targeted Medicine

Source: PPD

By Dirk Reitsma, M.D. and Michael Henning

Oncology is at the forefront of the revolution in personalized medicine. Personalized medicine seeks to identify individuals who will receive the most clinical benefit and least harm from a specific treatment by targeting genetic or other biomarkers associated with their disease. Enabled by advances in genetics and expanding use of biomarkers, oncology is pioneering the identification of disease subtypes and the clinical evaluation of targeted therapies aimed at treating them.

Oncology drug development must be streamlined to deliver these advanced therapies. Oncology trials are expensive, inefficient and suffer from high failure rates. Only 7 percent of drug candidates entering Phase I earn market approval; only a third of Phase III oncology trials achieve statistical significance in their primary endpoints. With the cost of developing a successful drug approaching $1.8 billion, the biopharmaceutical industry’s ability to deliver targeted oncology drugs is seriously threatened. Given the smaller patient populations typically eligible to use targeted products, drug development and treatment costs are higher compared to traditional chemotherapies.