The committee will (a) consider which of the existing and evolving approaches hold the greatest promise for improving the early detection and diagnosis of breast cancer, and (b) analyze the degree to which different stages in the development of innovative medical technologies* might act as bottlenecks, particularly for those technologies that promise to improve the early detection of breast cancer. Strategies to improve the efficiency of those steps will be identified and evaluated, with the goal of accelerating the flow of the most promising new approaches from the conceptual stage to clinical practice.
In addition to recommending strategies to enhance the discovery, development, and dissemination of approaches to the early detection and diagnosis of breast cancer, a fundamental and overarching goal of this study will be to improve the understanding of the media and the general public about the public health issues underlying the development of new approaches.
Specific tasks include:
- Develop a framework for examining new technologies for the early detection and diagnosis of breast cancer. This includes:
- Identifying the defining principles of effective new detection and diagnostic approaches.
- Identifying technological, financial, and regulatory obstacles to the development and use of these detection and diagnosis options in clinical practice.
- Consider the role of regulatory and coverage policies in the development of medical innovations, particularly those relevant to early detection and diagnosis of breast cancer. Related tasks include:
- Consider modifications to the FDA review processes that might facilitate new technology development.
- Consider coverage approval mechanisms that could accommodate the various developmental stages of new technologies. Possibilities include modular, interim, or conditional approval strategies.
- Examine the impact of current health care payment systems on the development and clinical application of new and innovation medical technology.
- Consider what role, if any, cost-effectiveness considerations should play in the development and regulation of new medical technologies.
* "Technology" is used here in the broadest sense and includes biology, drugs, software, and devices.
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