In the wake of the recent commotion surrounding flawed research at Duke University on diagnostic tools based on molecular patterns (“omics” tests), an Institute of Medicine (IOM) panel has issued a report entitled Evolution of Translational Omics: Lessons Learned and the Path Forward calling for more conscientious oversight of such research and more stringent validation before it is applied in clinical trials.
In a controversy that dates back to a 2006 Nature Medicine publication by Duke researchers, headed by Dr. Anil Potti, Duke expects to retract 27 papers, has already cancelled three clinical trials, and is facing a lawsuit brought by patients of those trials. IOM committee chair Dr. Gilbert Omenn, a computational biologist at the University of Michigan, said that the Duke scenario resulted from “a rush” to commercialize and license genomics-based tests in the clinic, adding that “there are a lot of lessons here that surely apply to other places.”.
The IOM report didn’t just find problems with Duke’s research and premature commercialization efforts; it also pointed to several problems that may be inherent to research that identifies patterns in large sets of molecules (e.g., DNA, RNA, proteins) such as omics-based testing, including “over-fitting” of data patterns due to relatively small patient sample populations, as well as the fact that the tests are so difficult to reproduce (which helps explain why so few have successfully reached the clinic). The report also specifically notes financial and institutional conflicts of interest that may have contributed to the oversight at Duke.
A recommended set of steps to more substantially validate omics tests is provided by the IOM report, which includes redundant tests from blinded samples across multiple institutions and a more proactive effort to share and review data among researchers.