Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health Workshop Summary (2009) / Chapter Skim
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5 Panel: Where Are the Gaps?
5 Panel: Where Are the Gaps?
Pages 53-64
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From page 53... ...
The critical step, however, occurs in the human brain, which absorbs the data, makes judgments about it, and integrates it with other known information. Most would agree, Quinn said, that the data have established that monoclonal antibodies which bind epidermal growth factor receptor (EGFR)
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From page 54... ...
Something that happens fairly often with diagnostic tests is that the 40 to 60 percent success range is already exceeded based on known information. For a genetic test, retrospective data may suggest an 80 or 90 percent likelihood of a particular result.
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From page 55... ...
There have been several generations of radiation therapies for prostate cancer over the last couple of decades, Quinn said. First was standard radiation, approximating fields where the prostate would be, then conformal radiation, which was somewhat more accurate, then a technology called Intensity Modulated Radiation Therapy (IMRT)
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From page 56... ...
Again, the working group found the evidence insufficient to recommend for or against genotyping as a way to predict adverse drug effects. In its review of Lynch syndrome, EGAPP found sufficient evidence to recommend offering genetic testing for Lynch syndrome, but decided that the evidence was insufficient to recommend a specific genetic testing strategy.
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From page 57... ...
Berg urged continued funding for dialogue such as the Roundtable, to help set goals for where genetic testing should be 10, 15, 20 years into the future, adequately addressing what is possible versus what would be useful.
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From page 58... ...
Private Payers One area that was not addressed in any depth during the workshop is the role of private payers. The seven largest health plans in the United States represent 100 million patients.
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From page 59... ...
Contextual factors must be considered, such as FDA approval, political pressure, or physician demand, and TRANSPERS is developing a taxonomy of evidence gaps. Private payers bring an important perspective to the evidence debate, but better mechanisms are needed to facilitate their involvement.
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From page 60... ...
Phillips added that the popular thought is that private payers tend to follow Medicare decisions. But even Medicare is not a monolithic plan, and local and national coverage decisions can differ.
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From page 61... ...
Another example he offered was that it was patients who saw the positive impact of mammogram screening for breast cancer who lobbied Congress for prostate-specific antigen screening for prostate cancer. A participant commented that companies should be thinking about prospective evaluations of medications during the development process, so that treatments come out with prospectively evaluated companion diagnostics.
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From page 62... ...
He asked the panel to comment on the extent to which international collaboration might be useful for translational research, noting that many other nations have complementary or more extensive registries, better electronic medical records, and single-payer systems. Berg agreed and said colleagues in other countries are more likely to be able to deliver on promises of research because they have health care systems that make coverage decisions differently than the United States, and they may not implement practices until they have a certain level of evidence.
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From page 63... ...
Nonetheless, Medicare implemented screening when former Senator Robert Dole developed prostate cancer, and members of Congress approved Medicare coverage of the screening test. There still is no RCT showing that radiation treatment at any stage of the disease provides any benefit.
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From page 64... ...
Although most would agree that it would be great to find opportunities to use genetic tests, so far in his practice, Berg did not know of anyone using a genetic test for a common clinical condition. To be a viable business model, the tests need to be applicable to common clinical scenarios.
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