- [Full text] The Human Genome Project, and recent advances in personalized genomics | RMHP
- Essentials of Genomic and Personalized Medicine
- The Human Genome Project, and recent advances in personalized genomics
- Genetics vs. genomics
The appropriate evidentiary threshold for practice needs to be vigorously addressed and calibrated, since neither the low nor the high thresholds we have presented are optimal. The main issues to solve are 1 which of the forty-four questions in the ACCE analytic framework for evaluating the use of a genomic test can be left out of consideration; 2 what type of evidence is needed; 3 what type of review process conducted by what type of group is adequate; and 4 what levels of government oversight and regulation are required.
The answers will vary depending on the characteristics of the genetic applications under consideration and what is already known about the tests.
Ultimately, we need to raise the threshold from the low bar that now exists and decide how to maximize the opportunity for health benefits from genomic medicine while minimizing harms. Obviously, this would require deliberation to get input from all stakeholders including consumers. Although there are no clear evidentiary thresholds in genomics for safety, efficacy, or value, government and the private sector must jointly develop decision rules based on clear-cut criteria that could be different for various tests and their intended uses. The process should also consider the development of an evidence threshold for a translation research model.
Many genetic tests will be in T2 research for years to come. A new model for the integration of selected genomic applications into practice as translation research could speed the translation of promising tests.
Over the past few years, several groups have developed new models for the implementation of translation research through risk sharing. In practice, the current concept of CED as used by the CMS applies only to a limited number of high-impact and high-cost technologies; therefore, an expansion would be required to cover promising genomic applications. Finally, we may also wish to look at the experiences of other countries as they grapple with similar issues. The United States can undoubtedly learn from how other countries address both the evidence threshold and diffusion into clinical practice.
For the long-term viability of genomic medicine, a solution to the thorny evidence threshold problem needs to emerge soon. Independent groups such as the EGAPP Working Group are already making progress in exploring the feasibility of delineating evidence thresholds for different applications. If implemented properly, newer collaborative approaches among stakeholders can begin to address the current dilemma in genomic medicine.
The recent HHS initiative on personalized health care that integrates genomics with health information technology including electronic health records will accelerate the future conduct of such translational research and surveillance in health care settings.
N ow is the time to establish a flexible and sustainable process for translation research and evaluation of promising genomic applications, with concomitant development of a workable mechanism for guiding coverage decisions. A major expansion of the U. Al Berg is a professor of community medicine at the University of Washington in Seattle.
Stephen Teutsch is executive director of outcomes research at Merck and Company Inc. The authors thank Marta Gwinn and Kathryn Kolor for valuable comments on an earlier draft of the paper. The authors declare no conflict of interest related to this work. The views expressed in this paper are those of the authors and not necessarily those of the Centers for Disease Control and Prevention.
Published online 1 November Research Article Health Affairs Vol. Muin J. Teutsch , and Linda A. Abstract An ongoing dilemma in genomic medicine is balancing the need for scientific innovation with appropriate evidence thresholds for moving technology into practice. Cited By A proposal of a new evaluation framework towards implementation of genetic tests. Building evidence and measuring clinical outcomes for genomic medicine. Health economic impact of liquid biopsies in cancer management.
[Full text] The Human Genome Project, and recent advances in personalized genomics | RMHP
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The Human Genome Project, and recent advances in personalized genomics
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