The US Food and Drug Administration (FDA) is pushing for a financial stimulus to wallop "regulatory science" -research that can help evaluate new better and faster treatment. Yesterday, the FDA chief Margaret Hamburg laid his case for regulatory research at the National Press Club while the FDA has published a report on the subject. The agency wants to spend $ 25 million next year in regulatory science, a small slice of $ 4 billion from the administration of President Barack Obama asked for the agency in 2011. The Congress has not yet approved this request.
FDA is trying to move forward, however, partly by the link with the most flush agencies. Last week, in collaboration with the National Institutes of Health (NIH), has announced four major grants totaling $ 9.4 million in regulatory science. (FDA contributed just under $ 1 million and gave the rest NIH). They include support for a heart-lung system for testing potential drugs and an effort to significantly streamline clinical trials.
"Our current approach [to trials] is horribly inefficient, and we need to do something better," says Roger Lewis, a doctor of emergency medicine at Harbor-University of California, Los Angeles, medical Center. Lewis helps guide a company called Consultants Berry founded by Donald Berry, a biostatistician at MD Anderson Cancer Center in Houston, Texas. He and Berry, as well as medical emergency physician William Barsan at the University of Michigan, will be to examine whether the design of the "adaptive" testing that incorporate new information in midcourse can answer medical questions. They also want to know what concerns researchers may have about this approach. adaptive designs examine how patients respond to treatment as a trial works and adjust the way people are assigned to a new therapy accordingly. the three led by Barsan, will test this approach in neurological studies such as stroke and cardiac arrest. The goal, says Barsan, is to use a network of existing neurological tests as a laboratory to examine the strategy to improve test.
FDA also wants to disperse the $ 25 million from a range of other projects: Linking specific ingredients in cigarettes smoking associated diseases; the development of new chemical tests to evaluate the safety of fish caught for food in the Gulf of Mexico following the oil spill in April there; and the development of better methods to characterize stem cells that could be given to patients.
"Billions of dollars have been invested in biomedical research", and those that have led to major advances, Hamburg said yesterday in his speech. "But now we lack the ability to effectively translate these developments in vital products for those in need. "
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