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Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer (2001)
Institute of Medicine (IOM)

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. "4 Development and Regulation of New Technologies." Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press, 2001.

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1996, the Federal Multi-Agency Consortium to Improve Women's Health was established to formalize collaborations between the medical establishment and the nation's defense, intelligence, space, and energy communities. This new consortium included NCI, OWH, FDA, CIA, the National Science Foundation, the National Aeronautics and Space Administration, the U.S. Departments of Defense, Energy, and Commerce, and the Health Care Financing Administration. The initial goal of the consortium was to catalog the state of the art for breast imaging modalities and to identify the scientific and technological needs for application of the technologies to breast cancer detection, diagnosis, and treatment. These needs were then translated into a problem statement1 of technical specifications that could be understood by engineers, physicists, and other scientists working on imaging technologies. Since its inception, several national public workshops have been held to facilitate technology transfer and to stimulate public-private partnerships for technology development and application to breast cancer (Final Report, 1998).

Similar initiatives that focus more generally on biomedical imaging in oncology have also been launched recently. The first NCI-industry forum and workshop on this topic was held in September 19992 following discussions between NCI and the National Electrical Manufacturers' Association (NEMA).3 The forum had four main objectives: (1) to bring together individuals involved in funding, research, regulation, and reimbursement of imaging technologies; (2) to expand the role of anatomic and functional-molecular imaging in oncology; (3) to develop strategies for application of technical advances in imaging to unmet clinical needs in cancer; and (4) to better understand the processes related to development, adoption, approval, and dissemination of imaging technologies in oncology. A second workshop to continue the dialogue was held in September 2000.4

The first large-scale collaborative clinical trials group devoted to the


1http://www.4woman.gov/owh/bcimage/frames2.htm. Statements were prepared for digital X-ray mammography, MRI, ultrasound imaging, positron emission tomography, and nuclear medicine, computer-aided diagnosis, three-dimensional interactive visualization, and image storage and transmission. The problem statement for each technology describes the current state-of-the art as well as the technological needs and roadblocks to assist researchers unfamiliar with breast imaging in assessing the potential for their own technology, capability, or expertise to help address the stated needs.
2For a meeting summary, see http://dino.nci.nih.gov/dctd/forum/summary.htm.
3NEMA is a trade organization for more than 600 companies, including 60 that produce diagnostic medical equipment.
4For a summary, see http://dino.nci.nih.gov/dctd/forum/summary00.htm.

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