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Anna Barker, deputy director of the National Cancer Institute, said a systemic reform of the clinical trial system is "long overdue".
Mr. Nagayama said Japan must also improve its clinical trial system to help get drugs to market faster.
A radical pro-business secretary could now, in principle, bypass the clinical trial system and the F.D.A. approval process and decide to approve a drug.
Such trials are intended to address some of the problems with today's clinical trial system.
In its preliminary, Phase I, vaccine trials the company plans to rely on its own clinical trial system rather than on the extensive AIDS vaccine trial network run by the National Institute of Allergy and Infectious Diseases.
"She had a huge effect on the regulations adopted in the 1960s to help create the modern clinical trial system," according to FDA history expert Daniel Carpenter, a professor of government at Harvard University, as quoted in the Post article.
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The clinical trials system cannot accommodate the present crop of promising but untested new drugs.
To the Editor: As a clinical investigator for more than 20 years, I have personally experienced the successes and frustrations associated with the publicly financed clinical trials system.
Repairing the clinical trials system is critical not only for health care reform but for the health of millions of Americans.
Despite compelling laboratory experiments and ongoing FDA pilot clinical trials, system performance, robustness, and generalization remain challenges.
But it might restore trust in a clinical trials system battered by revelations of how COX-2 inhibitors were tested and how safety data were revealed.
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