If you’re a regular reader of EBL, you know we’re huge fans of systematic reviews – studies in which researchers use sophisticated methods to bring together and evaluate the dozens, hundreds, or even thousands of articles on a topic.
We value these analyses because they collect all of the information available and then look at why and how each study differs. By looking at so many studies, researchers can make general conclusions, even though participants and study settings might be different.
So we took a great interest this week in a series of studies in the British Medical Journal making the case that many medical studies aren’t published, and therefore missing from systematic reviews and the decision-making processes of doctors and patients.
One of the studies found that fewer than half of the clinical trials funded by the National Institutes of Health from 2005 to 2008 were published in peer-reviewed journals within 30 months of study completion, and only 68 percent were published at all.
Another examined trials registered at the federal web site ClinicalTrials.gov during 2009. Of the 738 studies registered and subject to mandatory reporting guidelines (per the rules of the U.S. Food and Drug Administration), only 22 percent reported results within one year. (It’s interesting to note that trials of medicines in the later stages of development and those funded by the drug industry were more likely to have results reported.)
A third study re-analyzed 41 systematic reviews of nine different medicines, this time including unpublished clinical trial data from the FDA in each analysis. For 19 of the systematic reviews, the addition of unpublished data led to the conclusion that the drug was not as effective as originally shown. For 19 other reviews, the additional data led to the conclusion that the drug was more effective than originally shown.
Dr. Harlan Krumholz, a cardiologist at Yale and a internationally-respected expert in outcomes research, summarized the issue in his Forbes magazine blog, including some of the reasons that data goes unreported. (Among them, researchers may not be happy with the results or may shift focus to a new study. And medical journals may not be receptive to negative results.)
Whatever the reasons, the take-home message seems to be that researchers and publishers need to do a better job getting all of the information out in the public domain so that doctors and patients can truly make informed decisions.