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New science-based endpoints to accelerate oncology drug development
Gary J Kelloff1, Caroline C Sigman
1Division of Cancer Treatment and Diagnosis, Cancer Imaging Program, National Cancer Institute, Executive Plaza North Room 6038, 9000 Rockville Pike, Bethesda, MD 20892, USA. kelloffg@mail.nih.gov
European Journal of Cancer (Oxford, England : 1990)
|March 2, 2005
Summary
Developing new oncology drugs is costly and inefficient. This paper discusses novel biomarker strategies and technologies to improve drug evaluation, identify patient populations, and enhance treatment efficacy for better cancer care.
Area of Science:
- Oncology
- Biomarkers
- Drug Development
Background:
- High failure rates in oncology drug development, particularly in Phase III trials, are due to safety and efficacy issues, increasing costs.
- Advances in molecular understanding of cancer and new technologies necessitate improved strategies for evaluating oncology drugs.
Purpose of the Study:
- To present definitions and classifications of biomarkers for oncology drug development.
- To outline science-based criteria for validating biomarkers.
- To highlight new technologies for biomarker measurement and evaluation.
Main Methods:
- Review of current challenges in oncology drug development.
- Description of novel biomarker endpoints and their validation criteria.
- Discussion of emerging technologies including genomics, proteomics, advanced microscopy, and imaging techniques.
Main Results:
- Biomarkers are crucial for identifying patient populations, predicting toxicity, and demonstrating drug efficacy.
- New technologies offer promising tools for precise biomarker measurement.
- Validation criteria emphasize mechanistic plausibility, technological feasibility, and clinical utility.
Conclusions:
- Biomarker-driven strategies can accelerate oncology drug development and improve cost-effectiveness.
- Collaboration between researchers, regulators (FDA, NCI), academia, and industry is essential for advancing biomarker research and implementation.