A study published in The BMJ today has found staggeringly poor levels of clinical trial reporting from 51 leading academic medical centres in the USA.
The study looked at 4,347 studies that were completed between October 2007 and September 2010, and identified trials with missing results two years after the trial completion. For the 51 institutions, the proportion of trials published ranged from 10.8% to 40.3%, and proportion of results reported on ClinicalTrials.gov ranged from 1.6% to 40.7%.
There is not only a professional ethical obligation to report results on time, but a legal one too. The 2007 FDA Amendment Act makes it law in the US that any clinical drug trial must be registered, and report results within one year of trial completion. In this study only 29% of trials were found to have results published within two years, and only 13% were posted on ClinicalTrials.gov.
By July 2014, approximately 33% of the studies still had no results published or reported online at ClinicalTrials.gov.
Rates of dissemination of clinical trial results across academic institutions. Published with permission from BMJ 2016;352:i637
James Cockerill, Campaigns Manager, Sense about Science, co-founders of AllTrials said:
“It beggars belief that the vital step of reporting results in a clinical trial register continues to evade the research community. Missing results are a disservice to medical science, and a disservice to the thousands of clinical trial participants who take part in trials. These ‘leading’ academic institutions need to get their research house in order, immediately, without exception.”
The Independent – Drug trials not reported in line with ethical and legal demands, British Medical Journal says
Bloomberg – One-Third of Clinical Trial Results Never Disclosed, Study Finds