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Hiding in Plain Sight: Underreporting of Clinical Trial Results in Neurology.

Clinical trials are substantial financial investments for their sponsors and substantial time investments for participating clinicians and patients. Trials, when done well, can change the standard of care, offering new hope for some diseases or improved understanding for others. Yet there are persistent concerns that the results of many trials languish, unpublished and unreported, preventing the scientific community from acting on important clinical data. Sreekrishnan et al1 sought to quantify this underreporting specifically within the specialty of neurology. Examining 2072 neurology trials publicly registered in ClinicalTrials.gov, the authors found that the majority of trials, 52.2%, were never published, even several years after the trials closed. Underreporting of trials specifically in neurosurgery, as opposed to neurology, has never been quantified, although the 2 fields may involve overlap, as many of the neurology trials examined by Sreekrishnan et al1 involved neurosurgical procedures. ClinicalTrials.gov also sheds light on trial funding: the majority of trials were sponsored by industry (50.7%), with a much smaller number supported by the National Institutes of Health (NIH; 12.9%) and the US Federal government (7.1%). The source of funding appeared to influence publication rate, with 54.3% of projects funded by the NIH published compared with 46.8% of trials funded by non-NIH sources. The typical time to publication was just over 2 yr (26.4 mo), with vascular neurology having the fastest time to publication among subspecialties (18 mo).2 Considering that clinical trials are costly, time intensive, and potentially risky for patients, it is remarkable that the majority of trial results are not disseminated. Part of this low rate may stem from publication bias. Although the selective reporting of trials with positive rather than negative results is not new,2,3 it continues to play an outsized role in shaping clinical practice, even when inducements like mandatory clinical trial registration (ie, ClinicalTrials.gov) are enacted. Publication of clinical trials, especially those with negative results, remains vital, helping to improve future trials, steering resources away from fruitless therapies, and informing patients about better clinical approaches. Publication bias has its roots in both the trialists who write papers—or neglect to—and the journals that reject them. Encouragingly, there are some indications that publication bias has improved at the journal level, with more negative trials getting to press.4,5 Additionally, ClinicalTrials.gov encourages direct reporting of results through its system to mitigate the risk of biased journals. Nevertheless, despite the availability of this system, Sreekrishnan et al1 found that only 40.6% of neurology trials used this feature. How to increase reporting is an unresolved problem. Improved trial design, as recently discussed by Azad et al6 in this journal, will help make studies more publishable. Journal requirements for registration with ClinicalTrials.gov and prospective data sharing arrangements are already endorsed by the International Committee of Medical Journal Editors.7 Mandatory reporting of trial results is required for some studies, but compliance is low (∼22%).8 Although additional inducements or penalties might help, responsibility for trial reporting ultimately rests with those running these trials. Self-assessments, like that reported by Sreekrishnan et al,1 will help us evaluate our performance.