Results of nearly half of all clinical trials conducted in the last decade by big drug companies have not been published, according to an analysis of data from TrialsTracker, an online tool that identifies trials from ClinicalTrials.gov that haven’t published results 2 years after the end of the trial.
TrialsTracker was developed by the AllTrials consortium, a group calling for the results of all clinical trials to be published. The tool includes sponsors with more than 30 interventional trials and excludes phase 1 trials.
According to the analysis, since January 2006, trial sponsors completed 25,927 eligible trials and haven’t published results for 11,714 trials, or 45.2%. These 11,714 trials with missing results enrolled an estimated 8.7 million patients.
“We should all be outraged” by this, Síle Lane, director of campaigns at Sense about Science, which runs the AllTrials campaign, said in a news release.
“Everyone has been talking about this problem for far too long. We hope that increasing accountability will help to drive change forward. The TrialsTracker helps to identify the individual universities and companies with the most overdue trials,” added Ben Goldacre, MBBS, MRCPsych, one of the founders of the AllTrials campaign for clinical trial transparency and one of the researchers behind the TrialsTracker.
Dr Goldacre, and coauthor Anna Powell-Smith, with the Evidence-Based Medicine Data Lab, University of Oxford, United Kingdom, reported their analysis of TrialsTracker data online November 3 in F1000Research.
Drug Companies Dispute Findings
The analysis found that Sanofi had the largest number of missing trial results — 285 missing results from 435 eligible trials (65.5%).
But Ameet Nathwani, MD, chief of medical affairs for Sanofi, told Medscape Medical News the company “disagrees with the AllTrials analysis, which does not capture many of our publicly available clinical trial results. In fact, of the 285 study results deemed missing by AllTrials, Sanofi has made publicly available results for 255 (90%) of these studies on either the EU Clinical Trials Register or the Sanofi website. This means that, in total, Sanofi has made publicly available the results for 93% of the 435 studies identified by AllTrials, making us one of the most transparent clinical trial sponsors in the world.
Nov 28, 2016 0
Nov 28, 2016 0