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Suggested Citation:"Introduction." Institute of Medicine. 2010. Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12779.
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Introduction

Personalized cancer medicine is defined as medical care based on the particular biological characteristics of the disease process in individual patients. By using genomics and proteomics, individuals can be classified into subpopulations based on their susceptibility to a particular disease or response to a specific treatment. They may then be given preventive or therapeutic interventions that will be most effective given their particular characteristics.

In oncology, personalized medicine has the potential to be especially influential in patient treatment because of the complexity and heterogeneity of each form of cancer. However, the current classifications of cancer are not as useful as they need to be for making treatment decisions; current cancer classification evolved from morphology and may be misleading because it does not take into account abnormalities at the molecular level. As a result, treatment needs to evolve toward a focus on targeted treatments based on individual characterizations of the disease.

Although this concept has great promise, a number of policy issues must be clarified and resolved before personalized medicine can reach its full potential. These include technological, regulatory, and reimbursement hurdles. To explore those challenges, the National Cancer Policy Forum held a workshop, “Policy Issues in the Development of Personalized Medicine in Oncology,” in Washington, DC, on June 8 and 9, 2009. At this workshop experts gave presentations and commentary on the following areas:

Suggested Citation:"Introduction." Institute of Medicine. 2010. Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12779.
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  • The current state of the art of personalized medicine technology, including obstacles to its development and use by clinicians and patients.

  • The current approaches to test validation, including analytic validity, clinical validity, and clinical utility.

  • The regulation of personalized medicine technologies, including the approaches’ shortcomings.

  • Reimbursement hurdles that can hamper both the development and use of personalized medicine technologies.

  • Potential solutions to the technological, regulatory, and reimbursement obstacles to personalized medicine.

This document is a summary of the conference proceedings, which will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of personalized cancer medicine forward. The views expressed in this summary are those of the speakers and discussants, as attributed to them, and are not the consensus views of the participants of the workshop or of the members of the National Cancer Policy Forum.

Suggested Citation:"Introduction." Institute of Medicine. 2010. Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12779.
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Page 1
Suggested Citation:"Introduction." Institute of Medicine. 2010. Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12779.
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One of the challenges in treating cancer is the disease's complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of individuals will be given preventive or therapeutic interventions based on their susceptibility to a particular disease or their predicted response to a specific treatment. However, before the use of personalized cancer care can reach its full potential, the health care system must resolve a number of technological, regulatory, and reimbursement issues.

To explore these policy challenges, the National Cancer Policy Forum held the workshop Policy Issues in the Development of Personalized Medicine in Oncology in June 2009. Experts provided presentations on the current state of personalized medicine technology, as well as issues in the validation of, regulation of, and reimbursement for the predictive tests that underpin personalized medicine. Participants discussed the obstacles and possible solutions to further developing and using personalized medicine technologies. This document summarizes the workshop.

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