The National Breast and Cervical Cancer Early Detection Program Recommendations

The committee's recommendations fall into two general categories: those that aim to improve the development and adoption processes for new technologies (Recommendations 1 to 5) and those that aim to make the most of the technologies currently available for breast cancer detection (Recommendations 6 to 10).

1. Government support for the development of new breast cancer detection technologies should continue to emphasize research on the basic biology and etiology of breast cancer and on the creation of classification schemes for breast lesions based on molecular biology. A major goal of this research should be to determine which lesions identified by screening are likely to become lethal and thus require treatment. This approach would increase the potential benefits of screening while reducing the potential risk of screening programs.

• Funding should focus on the development of biological markers and translational research to determine the appropriate uses and applications of the markers, including functional imaging.

• Research on cancer markers should focus on screening as well as on downstream decisions associated with diagnosis and treatment.

• Funding priorities should include specimen banks (including specimens of early lesions), purchase and operation of high-throughput technologies for the study and assessment of genetic and protein markers, and new bioinformatics approaches to the analysis of biological data.

2. Breast cancer specimen banks should be expanded and researcher access to patient samples should be enhanced.

• Health care professionals and breast cancer advocacy groups should educate women about the importance of building tumor banks and encourage women to provide consent for research on patient samples.

• Stronger protective legislation should be enacted at the national level to prevent genetic discrimination and ensure the confidentiality of genetic test results.

• The National Cancer Institute (NCI) should devise and enforce strategies to facilitate researcher access to the patient samples in specimen banks. For example, the costs associated with the sharing of samples with collaborators should be included in the funding for the establishment and maintenance of the specimen banks, and specimen banks supported by government funds should not place excessive restrictions on the use of the specimens with regard to intellectual property issues.

3. Consistent criteria should be developed and applied by the Food and Drug Administration (FDA) for the approval of screening and diagnostic devices and tests.

• Guidance documents for determination of "safety and effectiveness," especially with regard to clinical data, should be articulated more clearly and applied more uniformly.

• Given the complexity of assessing new technologies, the FDA advisory panels could be improved by including more experts in biostatistics, technology assessment, and epidemiology.