Although oncology drug approvals are up, research shows that, on average, any one of those drugs on the market is ineffective for 75 percent of its patient population.
The difficulty of testing the safety and effectiveness of new oncology drugs is partly due to the fact that the disease itself is not so easily defined. In general, clinical trial patients have been grouped by the morphology of tumors and the stage of their disease. However, the introduction of scientifically and analytically validated biomarkers has provided a significant number of paths to improved patient care and drug development.
With the promise of personalized medicine through targeted agents, the need for new approaches in the design and conduct of early phase oncology trials has become more evident. A putative biomarker should be validated as early as possible in development for both ethical and practical reasons. Additionally, biomarkers can be used to make early go/no-go decisions for compounds in development.
Tune in live on October 14th at 11:30am ET to learn:
- What are biomarkers and how can they be used in novel ways?
- How to use biomarkers to determine diagnoses, diagnostic accuracy, treatment plans and tracking responses
- How to leverage PK/PD quantitative data to guide study design and development decisions
- How to develop a targeted vs. reactive patient recruiting plan
- Considerations for adaptive approach to trial design
- Lee Schacter, PhD, MD, FACP, Executive Medical Director, Oncology, Clinipace Worldwide
- Martha Bonino, Director, Strategic Accounts, Clinipace Worldwide
- Afshin Safavi, PhD, Founder & Chief Scientific Officer, BioAgilytix
Register today to reserve your spot. And be on the lookout for an accompanying eBook to follow the webinar!