In its quest to enroll one million people into its Precision Medicine Initiative, the US National Institutes of Health hopes to avoid the errors that sunk another large-scale project, the National Children's Study, Stat News' Sheila Kaplan reports.
The longitudinal NCS aimed to sequence the genomes of 100,000 babies and then follow those kids as they grew up, collecting environmental, lifestyle, and medical data from them. But a National Academy of Sciences report that came out in 2014 found that the project had become bogged down by scientific disagreements and mismanagement. The study was halted at the end of 2014, though last June lawmakers sought to resurrect the project in a slightly different form.
The question now, Kaplan writes, is whether the PMI can avoid the same pitfalls as it seeks even more volunteers than the NCS, but some researchers say it's already badly designed.
"I read the request for applications and I also read the advisory report to NIH, and I thought, if anybody in one of my epidemiology classes presented this as a study design, it would get an F," Nigel Paneth, a pediatrician and epidemiologist at Michigan State University, tells her.
The fate of NCS, Kaplan adds, is on the minds of NIH officials. "Believe me, it has occurred to us that we better not go down that same path," NIH Director Francis Collins tells her.
NCS took a long time — some 10 years — to get going during which science advanced and that led to changes to the study design over time. It was also besieged by disagreements regarding the best way to attract volunteers and measure outcomes, Kaplan notes. And it suffered from money troubles. NIH officials, she says, hope to avoid such delay with the PMI with its 2016 budget of $200 million.
"We aim to keep it rapidly moving, to attach itself to today's science, and to get that implemented quickly," Collins adds.