New guidelines for publishing biomarker studies encourage researchers to include aspects of their methodology that could influence biomarker measurement or interpretation. These guidelines are an update to an earlier statement, called Strengthening the Reporting of Observational Studies in Epidemiology, or STROBE. The new STROBE-ME report includes the prior recommendations, and adds 17 items specific to molecular epidemiology. The statement was simultaneously published in a number of journals, including the European Journal of Clinical Investigation, PLoS Medicine, and Preventive Medicine, in October.
"All of the STROBE statement we believe is very, very important. But there are ... additional points you need to take into consideration when you are also including a biomarker measurement within your study," says Imperial College London's Valentina Gallo, first author on the paper introducing the guidelines.
The idea for the additional guidelines originated with members of the Environmental Cancer Risk, Nutrition and Individual Susceptibility network, Gallo says. The network brings together both lab scientists and epidemiologists. "Just speaking about our research, it became clear that some more guidelines were needed in order to make these two disciplines talk better, one to the other," she says. The group then met twice to circulate a draft of the guidelines among its members and discuss its key points before finalizing it.
The aim, Gallo says, is to get researchers to report anything in their methods that could influence biomarker levels or interpretation, especially as more and more biomarkers are uncovered and measured through new, less-established methods. "Many of the biomarkers might change with many characteristics of sample drawing or the patient when the sample was drawn, or if, for example, the blood has been frozen or not and how many times," Gallo says. "The idea is that all these [possibilities] leading to publishing results on biomarkers should be made clear when describing the study to allow the readers to understand very well what was done and to interpret the result correctly."
The group hopes that journals will adopt this statement as criteria for publishing biomarker studies.