US Government
A controversial plan to study the health of 100,000 American babies in 21 years some points, but also highlights a multitude of weaknesses that could further delay its launch, an external review concluded. Criticism of Institute of Medicine (IOM) and the National Research Council panel (NRC) raises questions as to whether the national study for children (NCS) can maintain the necessary political support to ensure the financing of ambitious effort, which has already cost $ 1 billion and could require billions more in coming years.
NCS "has enormous potential, but it also presents many challenges ...," says the report June 16 IOM / NRC. To overcome the IOM / NRC recommends that the Chief the study, the National child health and human development Institute (NICHD), undertake major changes, including refine the guiding assumptions of the study and strengthening scientific input and monitoring. and it should drop an existing plan to enroll nearly half of children at birth, and instead register all earlier during the pregnancy of the mother.
"It's not like [NICHD needs] to start to square, "because a lot of ground to NCS has been asked, the president said Greg Duncan committee, an economist at the University of California, Irvine. But the necessary changes would probably delay the initial recruitment, now scheduled for 2015
NCS was born to a congressional request, made 14 years ago, the National Institutes of Health (NIH) follow a large group of children from birth to adulthood in order to understand how environmental factors, including social media and chemical pollutants affect health. Planners decided to recruit 100,000 women and their unborn babies by knocking on doors of households in a random sample of 100 US counties. But this approach was too expensive, so NICHD turned to other designs. Members of Congress have expressed concern in 2012 after NICHD after spending $ 1 billion, decided to pull the plug on 40 NCS sites run by academics and turn to large contractors working track 4,000 families he had already enrolled in a pilot study. In March 2013, Congress called for IOM to review the study and propose improvements.
In general, the panel of IOM / NRC approves the NCS concept. Similar studies are underway in Europe and Japan, he notes, but the American version would be more complete in part because researchers should collect comprehensive data on environmental exposures. The group also agreed with the decision of the NICHD to design the study as a "data collection platform" that will start to concentrate on only the tests some assumptions such as exposure to the kitchen dust exacerbates problems -and respiratory add later. But these "assumptions copies" should be more scientifically robust, IOM / NRC found.
The panel found fault, however, with how NCS planned to recruit subjects. Instead of registering 45,000 babies at birth and the same number before the birth, the panel calculated the study could enroll 95,000 mothers during pregnancy for the same cost, if it dropped plans separate studies of 10,000 women. These small studies should focus on specific issues such as exhibitions of preconception and the effects of natural disasters. Registration siblings, as planned, could also provide useful data on exposures preconception, the panel noted.
Such changes would NICHD to register participants for about $ 1.5 billion over 7 years, the panel estimates, with annual costs peaking at just over $ 300 million. (NIH now allocates $ 165 million per year for the study.) The total IOM / NRC seems to NCS on a least cost path that previous estimates of the NIH, who predicted the study could cost 3 billion $. But the estimate IOM / NRC does not include costs such as data archiving and storage of biological samples, the report notes. If NIH must also reduce costs, the signs said it would be preferable to fewer families that reduce exposure measurements.
The panel could not determine if the NICHD plan to enroll pregnant women through a sample of US hospitals would provide a representative group of the population that the recruitment of women through suppliers prenatal 100 counties in the original NCS. The problem is that "no such list [of all hospitals] exists," said Duncan.
scientific leadership of NCS is a major gap, the report found. Although the study has various advisory committees, "the process by which decisions are taken in the study and approved are opaque, "he said. NCS needs more expertise within its program office, the committee concluded, and a new external scientific advisory group which has the power to approve the design of the study.
These conclusions are justified to some critics NCS, including university scientists who were driven out of the study 2 years ago. "From my perspective, this is excellent," says pediatrician and epidemiologist Nigel Paneth of Michigan State University in East Lansing, who led an ancient site NCS in Detroit. "His conclusions are essentially the same as mine. They just put more good. "
Now that IOM / NRC has had its say, the question is whether NIH embrace its recommendations and if Congress is willing to continue funding the study.
* Correction, June 16, 4:35 p.m. :. the report of the National research Council and Institute of medicine, both part of the National Academies
* update, June 16, 4:35 p.m. NIH Director Francis Collins issued a statement in response to the report saying it "raises significant concerns" it. puts the main study pending. A team of experts will meet in coming weeks to advise Collins if the study is budget constraints "actually achievable" current data and, if so, how to implement the recommendations. Otherwise the panel will look at "new methods to answer key research questions that are most important for pediatric health today."
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