The clinical research process isn’t perfect, but like all scientific processes, it is constantly in flux, reviewing itself, and hopefully improving. One of the biggest problems to rear its head in recent years has been the trend towards certain trials going unpublished, for a variety of reasons. A new format of journal article has recently been introduced that hopes to tackle the problem and BMC Medicine, one of the top medical journals has already signed on to work with the new model.
The Registered Report model is a format where a study and its methodology are submitted to a journal before any actual data is collected. This report is peer-reviewed and if the study’s methodology is accepted as sound then the future publication of the completed results are confirmed regardless of the outcome of the study. This process incorporates two peer review stages, one when the Registered Report is first submitted, and then when the complete article with results is finished.
In some social science and psychology fields this Registered Report process has been in place for several years, but this is the first time it has been proposed and accepted into the field of medical clinical research.
The publishing, or often lack thereof, of negative or neutral clinical trial results has been a source of concern for many in the field of clinical medical research. With reports that up to half of all clinical trial results remain either unpublished or unfinished, significant anxiety abounds over the accuracy of our current system.
Some of these unpublished results are due to scientists running out of time and money, but others are undoubtedly more conspiratorial and problematic. Pharmaceutical companies not wanting to publish negative or neutral test results, or scientists not seeing professional value in bothering to publish the results, are all major problems in the clinical trial process that need to be overcome.
Another enormous problem this new model hopes to tackle is called outcome switching. This is where a team of researchers alter a trial’s primary outcome after the results of the trial are in. New outcomes could be silently added while older outcomes simply go unreported. The prominence of this kind of cherry-picking is a little frightening.
Notable campaigner against scientific misconduct, Dr Ben Goldacre, runs a website called Compare, which systematically tracked every trial published in five major medical journals over a four month period. Out of 67 trials checked, only 9 were shown to be entirely perfect and unsullied. Out of the remaining 58, either new outcomes were added or initial proposed outcomes were not ultimately reported.
Of course simply instituting this new Registered Reports step to the clinical trial process isn’t enough to get all researchers on board. Some scientists have expressed skepticism for the new model. From concerns an unscrupulous primary stage peer reviewer could scoop the research idea, to perceptions the process promotes inflexible clinical models by having to lay down a methodology so early, not all scientists are so readily embracing the potential change.
More cynical members of the community are also right to wonder if this model will actually result in more clinical trial results being published. After all, a funding commitment from a pharmaceutical company could indeed stipulate that Registered Reporting not be involved in a given trial. And with many university research departments spinning off commercial start-up arms designed to commodify their research outcomes, it’s not hard to imagine a reticence to publish negative results for a newly devised material, treatment or medicine.
It is worth trying to be optimistic about this new model, and hopefully it is a step towards a more comprehensive transparency in the clinical research field. Looking from the outside in, one would think that this model become the only way clinical results could be published. A more naive commenter could rightly ask why this isn’t a mandatory part of the journal process.