April 2020
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Full text: Tracy, D., Joyce, D., Albertson, D., & Shergill, S. (2020). Kaleidoscope. The British Journal of Psychiatry, 216(4), 238-239. doi:10.1192/bjp.2020.51
Read the full April 2020 Kaleidoscope column in BJPsych for free
Given our reliance on evidence-based decision-making, we need confidence in scientific publishing. There are increasing concerns about difficulties publishing negative results, and non-publication of ‘inconvenient’ data. This publishing behaviour is important because it distorts the available guidelines. In response to this, the 2007 USA Food and Drug Administration Amendments Act mandated sponsors of relevant trials to report their findings on the clinicaltrials.gov website within a year of the study end. DeVito et al downloaded data from all applicable studies between March 2018 and September 2019.1 They found only 63% of the 4022 relevant trials had reported on the website, with only 40% making their 1-year deadline. Sponsors who ran multiple trials did much better than those smaller ones that ran fewer trials. Interestingly, industry-led research did better than non-industry; it might be that they have more to lose through non-compliance, or have more professional systems in place. There has been no improvement with time as the system embeds, and crucially, the authors note the lack of enforcement. They calculated that if the rules had been applied properly, the Food and Drug Administration could have collected almost $4 billion in fines, but have not yet issued a single one. There are some prominent clinical and academic sites ‘leading’ the chart of poor performers: you might be surprised at the names if you turn to the primary paper. Pleasingly, and impressively, the authors openly provide their data and software so that others can test and re-use it, and are maintaining an updated website so that organisations can demonstrate improvements (http://fdaaa.trialstracker.net).