News/Commentary

This study is important to you but you could easily look at it and think that it looks too technical or skim enough to decide that this one is “not my problem.”

It is your problem. It is a problem for every patient in the world whose doctors rely on medical journals to follow the latest findings in their respective specialties.

A new study in the September 2 issue of The Journal of the American Medical Association reveals that a four-year old requirement for registering clinical trials is yielding only 45.5% of properly registered trials.

That requirement was set by the International Committee of Medical Journal Editors. Journal editors review, make judgments on submissions through a process called “peer review” (other experts review and give their opinions to journal editors). Yes, it is voluntary. No, you do not want governments involved in the process, politicizing research even more than it has been in recent years. Yes, it is important that researchers participate in registration to the fullest extent.

Reputations are at stake. No researcher wants to risk rejection in a way that would call reputation into question.

Their caution also is understandable because grant money is hard to come by.  To keep the grants coming, a researcher needs to establish a track record. This has made researchers even more cautious about what work they expose to public view.

Their caution is understandable but, as researchers, they need to find a way to deal with the aforementioned pressures so that they can participate in building a rich body of evidence in their fields.

This is supposed to be the age of “evidence-based medicine.” When the evidence is less than half complete, what does that do to the whole?

Nothing good.

From the JAMA abstract:

“Results: Of the 323 included trials, 147 (45.5%) were adequately registered (ie, registered before the end of the trial, with the primary outcome clearly specified). Trial registration was lacking for 89 published reports (27.6%), 45 trials (13.9%) were registered after the completion of the study, 35 (10.8%) were registered with no or an unclear description of the primary outcome, 39 (12%) were registered with no or an unclear description of the primary outcome, and 3 (0.9%) were registered after the completion of the study and had an unclear description of the primary outcome. Among articles with trials adequately registered, 31% (46 of 147) showed some evidence of discrepancies between the outcomes registered and the outcomes published. The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6% (19 of 23).”

As noted, even among the registered trials, there were differences between the goals at the outset and the findings at study’s end in one-third of the articles published in leading medical journals.

A simple example: How effective is a drug in curing XYZ condition? Researchers could find that, while it is not a cure, it greatly improves quality of life. That is excellent information to have, but that is not what they set out to measure.

New York Times

“Many researchers are ignoring a 2005 requirement that they register proposed clinical trials in a government database as a condition for publishing their results in medical journals. And the journals are publishing the papers anyway, a new study reveals.

“The study, a review of 323 articles published last year in leading medical journals, found that only 147 of the clinical trials — 45.5 percent — were properly registered before the end of the trial in a way that clearly stated the main outcomes being assessed. Even among the articles that were registered, almost a third had discrepancies between the outcomes described in the registry and the ones ultimately reported. (Emphasis added)

Of the trials that were not registered properly, 89 — more than half — were never entered in the National Institutes of Health’s clinical trials registry. The report appears in the Sept. 2 issue of The Journal of the American Medical Association.

“We’re asking people to tell readers honestly and transparently, ‘What did you do, and what did you find?’ ” said an author of the paper, David Moher, senior scientist at the Ottawa Hospital Research Institute in Canada.

Dr. Moher added that bias could easily be introduced when investigators changed the primary outcome they were measuring — moving the goalpost, so to speak. That might happen, for example, if a clinical trial is designed to determine whether a drug increases survival rates but investigators change the primary outcome to assessing if the drug improves quality of life. (Emphasis added)

Source: New York Times, September 4, 2009, Vital Signs

Citation: JAMA. 2009;302(9):977-984.