marker development are relevant to both biomedical imaging and in vitro diagnostics, in vivo imaging also entails a set of unique considerations, in part because it often requires administration of chemical agents, and thus has some similarity with drug development. Biomedical imaging will be addressed in a forthcoming workshop of the National Cancer Policy Forum, as this topic was beyond the scope of this report.

In recent decades, knowledge about the basic biology and biochemical pathways underlying cancers has increased tremendously, but translation of that knowledge to more effective patient care and better outcomes remains a challenge. Recent technological advances that enable examination of many potential biomarkers have fueled renewed interest in and optimism for developing biomarkers, and it is widely believed that biomarkers can and will be used to improve cancer screening and detection, to improve the drug development process, and to enhance the effectiveness and safety


Summary of Recommendations to Develop Biomarker-Based Tools for Cancer

Methods, Tools, and Resources Needed to Discover and Develop Biomarkers (Chapter 2)

  1. Federal agencies should develop an organized, comprehensive approach to biomarker discovery, and foster development of novel technologies.

  2. Industry and other funders should establish international consortia to generate and share precompetitive data on the validation and qualification of biomarkers.

  3. Funders should place a major emphasis on developing quantitative pathway biomarkers to broaden applicability.

  4. Funders should sponsor demonstration projects to develop biomarkers that can predict efficacy and safety in patients for drugs already on the market.

  5. Government agencies and other funders should sustain support for high-quality biorepositories of prospectively collected samples.

Guidelines, Standards, Oversight, and Incentives Needed for Biomarker Development (Chapter 3)

  1. Government agencies and other stakeholders should develop a transparent process to create well-defined consensus standards and

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