NIH hopes to avoid past missteps in launching new childrens study

first_img Sign up for our daily newsletter Get more great content like this delivered right to you! Country The U.S. National Institutes of Health (NIH) is gearing up for a large, long-term study of how environmental factors affect a child’s health. But please don’t call it the National Children’s Study (NCS).The NCS was launched more than a decade ago at the request of Congress; its goal was to follow 100,000 children from the womb to age 21. But last December, after spending $1.3 billion on planning and pilot testing, NIH Director Francis Collins ended the full NCS before the first child was enrolled. An Institute of Medicine report had found problems with its management, design, and cost, and scientific advisers told NIH the study was not feasible.Last month, Congress signaled that it wants NIH to try again. Spending panels in both the U.S. House of Representatives and the Senate included $165 million for it in NIH’s budget for 2016, with a House report referring to the NCS Alternative. NIH prefers to call it the Environmental influences on Child Health Outcomes (ECHO) program. The new study will focus on four areas of high public health concern: obesity, birth defects and other early outcomes, neurodevelopmental disorders (such as autism and depression), and airway diseases (such as asthma and allergies). Email One big change is that ECHO will knit together existing children’s studies rather than recruiting a new cohort. That should avoid the recruitment challenges and rising costs that plagued the NCS. It also hopes to move much more quickly than it did with the NCS.On Monday NIH put out a notice giving the community a 1-month deadline for input and this week is holding invitation-only roundtables for stakeholders. The aim is to have a final study plan by 1 October.ScienceInsider spoke yesterday with NIH Principal Deputy Director Lawrence Tabak about the new program. The conversation is edited for brevity.Q: NIH agreed last December that it wasn’t feasible to launch the NCS. Why is it back?A: This is not the NCS. This is a program that will focus on how a variety of parameters influence child health, with particular emphasis on peri-, pre-, and postnatal development. Q: How will this be different from the original NCS? A: We are going to be leveraging existing cohorts. That way, a good deal of the infrastructure will already be in place with regard to identification and enrollment of potential participants. It will allow us to ask very targeted questions where appropriate. Q: Why did you decide to launch a new version of the NCS?A: The science is what drives this. What influences childhood development and what sets up the antecedent of disease and conditions later in life is still very much an open set of questions.Q: Did Congress influence the decision? A: We have many stakeholders, and obviously Congress is one of those groups that we have to listen to.Q: The Request for Information describes a plan for fiscal year 2016. What happens after that? A: We are planning this to be a long-term study that we will fund over successive budget years. Obviously all this is subject to congressional funding, like with anything else that we do.Q: Are there some obvious cohort studies that might be part of the program?A: There’s been no outreach to the people who run this cohort. But by illustration, the nuMoM2b (new mom to be) study is a prospective cohort that’s looking at adverse pregnancy outcomes [in 10,000 women]. You could envision additional resources being applied so that children could be followed longitudinally. Importantly, the nuMoM2b study in common with other cohorts has a wealth of information about the moms. There may be [biological] samples that they have available.This is all hypothetical. We are not going to be reaching out to cohort leaderships. Eventually there will be a funding opportunity announcement that people can respond to.Q: Do you have a target number for total enrollment? A: There is no target number because this is being driven by scientific decisions. For some diseases and conditions, a very focused cohort of hundreds of people may be absolutely appropriate. In other instances you may need larger numbers.Q: Will data be comparable across the different cohort studies? A: The plan will be to create common data elements. The ability to merge seemingly disparate data sets is becoming easier. But we are not going to have uniform everything from the outset because that would be a different kind of study.Q: Existing studies may not have collected the data needed to study environmental influences on early development. Will the program recruit new pregnancies? A: Initially the plan is to take advantage of existing programs.We don’t rule out the possibility that there can be new enrollment. You could envision that, if a particular cohort was studying a woman’s first pregnancy, by providing resources to that group you could then study a second pregnancy. Then you would have a wealth of data from the first pregnancy and be able to compare to the events of the second pregnancy.Q: Will contract organizations or academic researchers run the study? A: People will compete to address the elements that are in the funding opportunity announcements. Then we will be informed by peer review. 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