Robert Califf questioned whether the integration of the basic sciences and the clinical setting could ever be realized. The current system identifies many preventable adverse drug events, events caused by situations that are very well described, yet adequate clinical systems to deal with them are not in place. In prescribing antithrombotic drugs, for example, the wrong dose is given about a third of the time. In such cases, one must administer a test whose results are not available for 2 days, and then figure out how to deal with the problem. Woodcock disagreed, suggesting that if a new technology is introduced with explicit instructions for its use, the health care system will apply it. As an example, she pointed to the experience with abacavir (see Chapter 6).

Along the same lines, Frazier commented that health care providers will not actively follow the search for biomarkers and adopt each as it is discovered. Instead, when a biomarker is validated as being clinically useful, doctors will adopt it. If doctors are provided with a useful bottom line, they will apply it.

Caskey said that while analyzing their compounds, many of the large pharmaceutical companies use different tests to measure the same outcome. Thus the decision that is made at Pfizer will not be the same as that made at Merck or that made at Abbott. Caskey suggested that the FDA undertake a research initiative to determine which of these tests are most effective in predicting clinical safety. When a drug was approved and launched, it could be subjected to the testing systems proposed by each of the companies, and the actual clinical results could be compared with those of the various testing systems. Caskey suggested that partial funding for these efforts could come from the National Institutes of Health.


In her concluding comments, Woodcock said it will be important to keep an eye on the long-term goal. That goal is not just to fix problems that occur when a drug enters the market. Rather, it is to move medicine to a more scientific basis, something for which the necessary tools exist. What is lacking is the system to make it happen. Summarizing the workshop’s take-away messages, Woodcock said that efforts to create standards should be greatly intensified, especially in areas in which data from different sources will be linked. She emphasized that the science is emerging, and the community needs to ensure that it is put to the best use as quickly as possible; the next steps need to be considered and discussed now.

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