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Oct. 4th, 2011 12:14 am![[identity profile]](https://www.dreamwidth.org/img/silk/identity/openid.png)
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кнтекста много, затем под катом
I once advised a U.S. hospital that was conducting a clinical trial of a new drug for a foreign pharmaceutical firm. These tests form the basis for new drug applications to the U.S. Food and Drug Administration (FDA). The overseas drug company was refusing to follow an FDA rec- ommendation about how the trial should be conducted. The FDA wanted one sort of informed consent form used with patients taking the experi- mental drug, and the foreign firm was adamant that it would use its own form. The disagreement was threatening the whole project because the FDA might ultimately reject all the findings in the study if the wrong form was used.
The issue was all the more bizarre because the hospital and the for- eign firm shared significant interests. Both wanted to see the project through to a successful conclusion, and millions of dollars as well as the professional reputations of both parties were at risk.
This negotiation had all the earmarks of a disaster until I asked the hospital’s research director to identify the specific decision maker at the drug firm who was saying “no.” This question forced the executive to fo- cus his attention on a specific person instead of “the client.” It turned out that a foreign-trained physician with no U.S. medical experience was call- ing the shots. Then I asked why this particular physician might be say- ing “no.”
All of a sudden the ideas started popping. First, the foreign physician’s experience was with his countr y’s version of the FDA, and that agency would not throw out a study based on this sort of issue.
абсолютно не понимаю логику последней фразы. о чем это?
I once advised a U.S. hospital that was conducting a clinical trial of a new drug for a foreign pharmaceutical firm. These tests form the basis for new drug applications to the U.S. Food and Drug Administration (FDA). The overseas drug company was refusing to follow an FDA rec- ommendation about how the trial should be conducted. The FDA wanted one sort of informed consent form used with patients taking the experi- mental drug, and the foreign firm was adamant that it would use its own form. The disagreement was threatening the whole project because the FDA might ultimately reject all the findings in the study if the wrong form was used.
The issue was all the more bizarre because the hospital and the for- eign firm shared significant interests. Both wanted to see the project through to a successful conclusion, and millions of dollars as well as the professional reputations of both parties were at risk.
This negotiation had all the earmarks of a disaster until I asked the hospital’s research director to identify the specific decision maker at the drug firm who was saying “no.” This question forced the executive to fo- cus his attention on a specific person instead of “the client.” It turned out that a foreign-trained physician with no U.S. medical experience was call- ing the shots. Then I asked why this particular physician might be say- ing “no.”
All of a sudden the ideas started popping. First, the foreign physician’s experience was with his countr y’s version of the FDA, and that agency would not throw out a study based on this sort of issue.
абсолютно не понимаю логику последней фразы. о чем это?