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BETHESDA, MD.– The National Children’s Study, congressionally mandated in 2000 to better understand phenotypical influences on American-born children, has been scrapped.
The longitudinal cohort study intended to observe 100,000 children from birth to at least age 21 years has provided infeasible, according to Dr. Francis S. Collins, director of the National Institutes of Health, explaining his decision to end it. “This study failed to achieve its goals,” based in large part to its cumbersome management by multiple committees, adherence to outdated biological science and technologies, and excessive costs during an era of austerity at the NIH, Dr. Collins said.
In an internal memo issued by the Advisory Committee to the Director of the NIH, posted on the NIH website along with Dr. Collins’s statement, the NCS was faulted for its “overly complex” sampling design and an overall design that was “incomplete even after years of effort.” The internal report also declared that despite the NCS’s intended launch date of 2015, there was no discernible manual of standard protocols.
Pending the ACD report, which was based on a similar review of the NCS earlier this year by the National Academies of Science, Dr. Collins previously had suspended the study in June.
The NCS’s roots go back to a 1990s White House Task force that concluded the United States sorely lacked data linking environmental exposure, development, and health outcomes in children. Congress then passed the Children’s Health Act of 2000 authorizing the National Institute of Child Health and Human Development to conduct a study to address that need. Since funding for the mandate began in 2007, nearly $1.3 billion have been allocated to the NCS, despite what the ACD concluded was the study’s lack of any discernible impact.
The ACD report also found that because the scientific landscape has changed dramatically since the NCS was passed into law, other nimbler and more accurate pathways to data collection could be tapped in lieu of the study, such as partnering with health insurers whose interest in research has ascended in the last decades or collaborating with multicenter networks already employing newly devised sophisticated phenotyping technologies to investigate similar concerns.
Dr. Collins said he agreed with the ACD’s overall conclusion that the need for conclusive data linking childhood health outcomes with environmental and developmental influences, but that these aims could be achieved by considering “alternative approaches ... in consultation with the broader scientific community.”
Dr. Collins said that data from the NCS’s pilot Vanguard Study, which tested potential study methodologies, will be archived and available upon request to investigators interested in conducting secondary analyses. According to the ACD report, the Vanguard project yielded 112 papers, primarily on study design, but with some preliminary results related to environmental exposure in childhood. David Murray, Ph.D., NIH associate director for prevention, will head the study’s closure. Meanwhile, Dr. Collins said that he will lead the NIH in talks with Congress and the Obama Administration to fully discontinue the NCS.
On Twitter @whitneymcknight
BETHESDA, MD.– The National Children’s Study, congressionally mandated in 2000 to better understand phenotypical influences on American-born children, has been scrapped.
The longitudinal cohort study intended to observe 100,000 children from birth to at least age 21 years has provided infeasible, according to Dr. Francis S. Collins, director of the National Institutes of Health, explaining his decision to end it. “This study failed to achieve its goals,” based in large part to its cumbersome management by multiple committees, adherence to outdated biological science and technologies, and excessive costs during an era of austerity at the NIH, Dr. Collins said.
In an internal memo issued by the Advisory Committee to the Director of the NIH, posted on the NIH website along with Dr. Collins’s statement, the NCS was faulted for its “overly complex” sampling design and an overall design that was “incomplete even after years of effort.” The internal report also declared that despite the NCS’s intended launch date of 2015, there was no discernible manual of standard protocols.
Pending the ACD report, which was based on a similar review of the NCS earlier this year by the National Academies of Science, Dr. Collins previously had suspended the study in June.
The NCS’s roots go back to a 1990s White House Task force that concluded the United States sorely lacked data linking environmental exposure, development, and health outcomes in children. Congress then passed the Children’s Health Act of 2000 authorizing the National Institute of Child Health and Human Development to conduct a study to address that need. Since funding for the mandate began in 2007, nearly $1.3 billion have been allocated to the NCS, despite what the ACD concluded was the study’s lack of any discernible impact.
The ACD report also found that because the scientific landscape has changed dramatically since the NCS was passed into law, other nimbler and more accurate pathways to data collection could be tapped in lieu of the study, such as partnering with health insurers whose interest in research has ascended in the last decades or collaborating with multicenter networks already employing newly devised sophisticated phenotyping technologies to investigate similar concerns.
Dr. Collins said he agreed with the ACD’s overall conclusion that the need for conclusive data linking childhood health outcomes with environmental and developmental influences, but that these aims could be achieved by considering “alternative approaches ... in consultation with the broader scientific community.”
Dr. Collins said that data from the NCS’s pilot Vanguard Study, which tested potential study methodologies, will be archived and available upon request to investigators interested in conducting secondary analyses. According to the ACD report, the Vanguard project yielded 112 papers, primarily on study design, but with some preliminary results related to environmental exposure in childhood. David Murray, Ph.D., NIH associate director for prevention, will head the study’s closure. Meanwhile, Dr. Collins said that he will lead the NIH in talks with Congress and the Obama Administration to fully discontinue the NCS.
On Twitter @whitneymcknight
BETHESDA, MD.– The National Children’s Study, congressionally mandated in 2000 to better understand phenotypical influences on American-born children, has been scrapped.
The longitudinal cohort study intended to observe 100,000 children from birth to at least age 21 years has provided infeasible, according to Dr. Francis S. Collins, director of the National Institutes of Health, explaining his decision to end it. “This study failed to achieve its goals,” based in large part to its cumbersome management by multiple committees, adherence to outdated biological science and technologies, and excessive costs during an era of austerity at the NIH, Dr. Collins said.
In an internal memo issued by the Advisory Committee to the Director of the NIH, posted on the NIH website along with Dr. Collins’s statement, the NCS was faulted for its “overly complex” sampling design and an overall design that was “incomplete even after years of effort.” The internal report also declared that despite the NCS’s intended launch date of 2015, there was no discernible manual of standard protocols.
Pending the ACD report, which was based on a similar review of the NCS earlier this year by the National Academies of Science, Dr. Collins previously had suspended the study in June.
The NCS’s roots go back to a 1990s White House Task force that concluded the United States sorely lacked data linking environmental exposure, development, and health outcomes in children. Congress then passed the Children’s Health Act of 2000 authorizing the National Institute of Child Health and Human Development to conduct a study to address that need. Since funding for the mandate began in 2007, nearly $1.3 billion have been allocated to the NCS, despite what the ACD concluded was the study’s lack of any discernible impact.
The ACD report also found that because the scientific landscape has changed dramatically since the NCS was passed into law, other nimbler and more accurate pathways to data collection could be tapped in lieu of the study, such as partnering with health insurers whose interest in research has ascended in the last decades or collaborating with multicenter networks already employing newly devised sophisticated phenotyping technologies to investigate similar concerns.
Dr. Collins said he agreed with the ACD’s overall conclusion that the need for conclusive data linking childhood health outcomes with environmental and developmental influences, but that these aims could be achieved by considering “alternative approaches ... in consultation with the broader scientific community.”
Dr. Collins said that data from the NCS’s pilot Vanguard Study, which tested potential study methodologies, will be archived and available upon request to investigators interested in conducting secondary analyses. According to the ACD report, the Vanguard project yielded 112 papers, primarily on study design, but with some preliminary results related to environmental exposure in childhood. David Murray, Ph.D., NIH associate director for prevention, will head the study’s closure. Meanwhile, Dr. Collins said that he will lead the NIH in talks with Congress and the Obama Administration to fully discontinue the NCS.
On Twitter @whitneymcknight
