Federal officials are pulling the plug on an ambitious scheme hatched 14 years ago to track the health of 100,000 US children from before birth through 21. the National children age study (NCS), which is struggling to take off and has already cost over $ 1.2 billion, has too many flaws to achieve in a tight budget environment, said advisers today National Institutes of Health (NIH) Director Francis Collins. He announced that he dismantles the study immediately.
Meanwhile, councilors approved the objectives of the study and urged NIH to fund related research. NIH now plans to find a way to do it by redirecting a portion of NCS $ 165 million in funding for 2015, Collins said today at a meeting of the Advisory Committee to the NIH director (ACD).
Collins insisted that the news is not all bad. "It does not kill the study. It is withdrawing a study as had been previously envisaged. But it opens up a much wider range of scientific backgrounds to try to achieve these goals, we are all agreed highly worthwhile and worthy of that kind of attention, "he said.
A researcher who was involved with NCS since it began, said he was not surprised by the death of NCS. "It's a bittersweet moment. I think it was not only the right thing, it was the only thing that could be done," said pediatrician and epidemiologist Nigel Paneth of Michigan State University in East Lansing, part a group of university researchers who until recently led the research websites NCS.
Congress called for NCS in 00, describes a longitudinal study that would look the influences of a variety of factors, psychosocial chemicals on the development and health of children. the planners decided to include 100,000 children before birth and investigate a series of assumptions developed by hundreds of scientists. to assemble a representative sample of the population of the United States, they recruit pregnant women knocking on doors in a random sample of 100 counties. in 07, funding ramp for a driver called the Vanguard study .
But the recruitment plan proved too heavy, so NCS tested other designs. Concerned about costs in 2012 NIH abandoned the NCS 40 sites in the academic and transformed the 5,000 children enrolled in the Vanguard study over a few large contractors. It also reduced then- $ 194 million by year's budget NCS.
The changes sparked an outcry researchers at NCS sites 40, who argued that the new NCS scheme would jeopardize the objectives of the study. Congress then called for an Institute of Medicine (IOM) and the National Research Council (NRC) review. The June 2014 report of that panel concluded that NCS had great potential, but found problems with its design and management. Collins put the study on hold and asked a CDA Working Group to advise it on its future.
The group, co-chaired by Philip Pizzo and Russ Altman of Stanford University in Palo Alto, California, released its report today. The group agrees with the need to study how the exposure in early life affect health. But he agreed with the screen IOM / NRC that there are many problems with NCS, which would likely cost billions of dollars. Despite years of planning, "there is no protocol," Pizzo said, and development can take 18 to 24 months.
In addition, the study as currently considered ignores the new science, such as the role of microbial communities in health. and it is not intended to make use of new technologies such as social media and electronic medical records that could lower costs.
the working group also agreed with the IOM that the management team of the study lack of appropriate scientific expertise. When they consulted with experts from the environmental health, epidemiology and community pediatrics, most said their NCS should be redesigned or abandoned the conclusion of the working group. NCS, "as currently presented, is not possible."
the report recommends that the Office of the NCS program at NIH be dismantled and the Vanguard study be mothballed, with existing data and biospecimens made available to researchers outside. It also recommends a "series of studies have focused smaller" who "could make the initial objectives of the NCS more workable, feasible and affordable."
Collins said he immediately moves to carry out these recommendations. It will close the Office of the NCS program, which has about 25 staff members, and eliminate contracts for the Vanguard study and other work NCS.
NIH also expected to redirect some funding NCS, a plan that Congress has already approved. The 2015 omnibus spending bill moving through Congress declares that $ 165 million allocated for NCS could instead go to the NIH Institutes to "support activities related to the goals and objectives of the NCS." This "could be very exciting," said Collins.
Paneth said former NCS investigators are already thinking of ways they could conduct smaller studies with some of the same goals. If funding is not going to related work, "which would be a very positive result of this," he said. But as he points out, a question is whether the additional funding will continue beyond 2015. At the meeting today, Collins noted that NIH already spends about $ 1.2 billion per year on research involving environmental influences on children's health.
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