NIH cancels massive U.S. children’s study

Federal officials are pulling the plug on an ambitious plan hatched 14 years ago to follow the health of 100,000 U.S. children from before birth to age 21. The National Children’s Study (NCS), which has struggled to get off the ground and has already cost more than $1.2 billion, has too many flaws to be carried out in a tight budget environment, advisers today told National Institutes of Health (NIH) Director Francis Collins. He announced he is dismantling the study immediately.

At the same time, the advisers endorsed the aims of the study and urged NIH to fund related research. NIH now plans to figure out a way to do that by redirecting some of NCS’s $165 million in funding for 2015, Collins said today at a meeting of the NIH Advisory Committee to the Director (ACD).

Collins insisted that the news is not all bad. “This is not killing the study. It is discontinuing a study in the form that had been previously contemplated. But it is opening up a much broader array of scientific horizons to try to accomplish those goals, which we all strongly agree are worthwhile and highly deserving of that kind of attention,” he said.

One researcher who has been involved with NCS since it began says he’s not surprised by NCS’s demise. “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, who is part of a group of academic researchers who until recently led NCS research sites.

Congress called for NCS in 2000, outlining a longitudinal study that would look at the influences of a range of factors, from chemical to psychosocial, on child development and health. Planners decided to enroll 100,000 children before birth and investigate a range of hypotheses developed by hundreds of scientists. To assemble a representative sample of the U.S. population, they would recruit pregnant women by knocking on doors in a random sample of about 100 counties. In 2007, funding ramped up for a pilot called the Vanguard Study.

But the recruitment plan proved too cumbersome, so NCS tested other designs. Concerned about costs, in 2012 NIH dropped the 40 NCS sites at academic institutions and turned the 5000 children enrolled in the Vanguard Study over to a few large contractors. It also slashed NCS’s then-$194-million-a-year budget.

The changes sparked an uproar from researchers at the 40 NCS sites, who argued that the new NCS plan would compromise the study’s goals. Congress then called for an Institute of Medicine (IOM) and National Research Council (NRC) review. That panel’s June 2014 report concluded that NCS had great potential, but found problems with its design and management. Collins put the study on hold and asked a working group of the ACD to advise him on its future.

That 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 exposures early in life affect health. But it concurred with the IOM/NRC panel that there are numerous problems with NCS, which would likely cost billions of dollars. Despite years of planning, “there is no protocol,” Pizzo said, and developing one could take 18 to 24 months.

In addition, the study as currently envisioned does not take into account new science, such as the role of microbial communities in health. And it is not designed to make use of new technologies such as social media and electronic medical records that could bring down costs.

The working group also agreed with IOM that the study’s management team lacks appropriate scientific expertise. When they consulted with experts from the environmental health, epidemiology, and pediatrics community, most told them NCS should be redesigned or discontinued. The working group’s conclusion: NCS, “as currently outlined, is not feasible.”

The report recommends that the NCS program office at NIH be disassembled and the Vanguard Study be mothballed, with existing data and biospecimens made available to outside researchers. It also recommends a “series of smaller focused studies” that “could make the original goals of the NCS more achievable, feasible, and affordable.”

Collins said he is moving immediately to carry out these recommendations. He will close the NCS program office, which has about 25 staff members, and phase out contracts for the Vanguard Study and other NCS work.

NIH also expects to redirect some of NCS’s funding, a plan that Congress has already endorsed. The 2015 omnibus spending bill moving through Congress states that the $165 million allocated for NCS could instead go to NIH institutes to “support activity related to the goals and objectives of the NCS.” That “could be pretty exciting,” Collins said.

Paneth says former NCS investigators are already thinking about ways that they could conduct smaller studies with some of the same objectives. If funding does go for related work, “that would be a very positive outcome of this,” he says. But as he notes, one question is whether the extra funding will continue beyond 2015. At today’s meeting, Collins noted that NIH already spends about $1.2 billion a year on research involving environmental influences on children’s health.

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