Drug Development in Oncology in the Era of Precision Medicine
Cancer research is complex: trials require specific design expertise and often include biomarker and companion diagnostics, and failure rates tend to be higher than for drugs tested in other therapeutic areas. To mitigate risks associated with these complex studies, the right choice of endpoints, adequate definition of selection criteria, sensible use of safety and efficacy assessments, and state-of-the-art statistical planning, analysis and modelling tailored to oncology is vital.
This article will highlight some of the challenges of new trial designs, as well as perspectives on how to speed up drug development in the era of precision medicine.
Written by Prof. Christophe Le Tourneau, MD, PhD – Senior Medical Oncologist Institut Curie and Full Professor of Medicine – Paris Saclay University & Dr. Everardo Saad, MD – Medical Director – IDDI. Published in American Pharmaceutical Review, June 16, 2021