A news story by the American health news website STAT has appeared in my Twitter feed many times over the last few days.
The story claims to show that “prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments”. They looked at whether results of clinical trials that should have been posted on the clinicaltrials.gov website actually were posted, and found that many of them were not. It’s all scary stuff, and once again, shows that those evil scientists are hiding the results of their clinical trials.
Or are they?
To be honest, it’s hard to know what to make of this one. The problem is that the “research” on which the story is based has not been published in a peer reviewed journal. It seems that the only place the “research” has been reported is on the website itself. This is a significant problem, as the research is simply not reported in enough detail to know whether the methods it used were reliable enough to allow us to trust its conclusions. Maybe it was a fantastically thorough and entirely valid piece of research, or maybe it was dreadful. Without the sort of detail we would expect to see in a peer-reviewed research paper, it is impossible to know.
For example, the rather brief “methods section” of the article tells us that they filtered the data to exclude trials which were not required to report results, but they give no detail about how. So how do we know whether their dataset really contained only trials subject to mandatory reporting?
They also tell us that they excluded trials for which the deadline had not yet arrived, but again, they don’t tell us how. That’s actually quite important. If a trial has not yet reported results, then it’s hard to be sure when the trial finished. The clinicaltrials.gov website uses both actual and estimated dates of trial completion, and also has two different definitions of trial completion. We don’t know which definition was used, and if estimated dates were used, we don’t know if those estimates were accurate. In my experience, estimates of the end date of a clinical trial are frequently inaccurate.
Some really basic statistical details are missing. We are told that the results include “average” times by which results were late, but not whether they are mean or medians. With skewed data such as time to report something, the difference is important.
It appears that the researchers did not determine whether results had been published in peer-reviewed journals. So the claim that results are being hidden may be totally wrong. Even if a trial was not posted on clinicaltrials.gov, it’s hard to support a claim that the results are hidden if they’ve been published in a medical journal.
It is hardly surprising there are important details missing. Publishing “research” on a news website rather than in a peer reviewed journal is not how you do science. A wise man once said “If you have a serious new claim to make, it should go through scientific publication and peer review before you present it to the media“. Only a fool would describe the STAT story as “excellent“.
One of the findings of the STAT story was that academic institutions were worse than pharmaceutical companies at reporting their trials. Although it’s hard to be sure if that result is trustworthy, for all the reasons I describe above, it is at least consistent with more than one other piece of research (and I’m not aware of any research that has found the opposite).
There is a popular narrative that says clinical trial results are hidden because of evil conspiracies. However, no-one ever has yet given a satisfactory explanation of how hiding their clinical trial results furthers academics’ evil plans for global domination.
A far more likely explanation is that posting results is a time consuming and faffy business, which may often be overlooked in the face of competing priorities. That doesn’t excuse it, of course, but it does help to understand why results posting on clinicaltrials.gov is not as good as it should be, particularly from academic researchers, who are usually less well resourced than their colleagues in the pharmaceutical industry.
If the claims of the STAT article are true and researchers are indeed falling below the standards we expect in terms of clinical trial disclosure, then I suggest that rather than getting indignant and seeking to apportion blame, the sensible approach would be to figure out how to fix things.
I and some colleagues published a paper about 3 years ago in which we suggest how to do exactly that. I hope that our suggestions may help to solve the problem of inadequate clinical trial disclosure.