Hidden clinical trial data are systematically undermining doctors’ abilities to prescribe treatment with confidence. A whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money.
As of January 2013, the BMJ will no longer publish any trial of drugs or devices where the authors do not commit to making the relevant anonymised patient level data available, upon reasonable request.
On this page we are documenting some of the BMJ’s coverage of adverse outcomes associated with hidden clinical trial data. We are also highlighting the extent of the problem, as shown in our hidden data special issue, published in 2012.
We are also asking you to help us catalogue drugs, devices, and treatments for which a lack of complete clinical trial data has resulted in a skewed evidence base. Fill in our online form to tell us where and when you have seen this reported.
2013 is fast becoming the year of open data. Trish Groves, deputy editor of the BMJ, has blogged with an extensive list of recent developments and upcoming milestones.. In a separate blog, she outlines the current state of data-sharing, and how different companies are approaching the issue.
One key development is the European Medicines Agency’s plan to proactively share all of the clinical trial data submitted to it by companies seeking regulatory approval for a drug or device.
This seachange in transparency came in 2010, after perennial open data advocate Peter Gøtzsche, director of the Nordic Cochrane Centre, sought a ruling from the European Ombudsman on the right of the public to scrutinize those data. This changed their policy and they are now leading the field in allowing external evaluation.
That plan is now under threat as two companies, AbbVie and InterMune, have obtained an interim ruling from the General Court of the European Union to prevent the agency from data sharing, arguing that the patient level data requested “did not meaningfully contribute to the scientific review or evaluation of our products”, read some of the backstory in Jim Murray's BMJ blog.
The BMJ, working with the BMA, has requested leave from the court to intervene in the case.
New research from the University of North Carolina have estimated the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public.. The researchers have concluded that around 29% of trials registered on ClinicalTrials.gov are still unpublished 5 years later.
Elizabeth Loder, associate editor at The BMJ and associate professor of neurology at Harvard Medical School, has written a feature "Sharing data from clinical trials: where we are and what lies ahead" outling the promises and progress towards open-data that have been made so far.
Peter Doshi, post-doctoral fellow at Johns Hopkins University School of Medicine announced a new initiative Restoring invisible and abandoned trials: a call for people to publish the findings. In this analysis article, Doshi explains how provision of access to data released through FOI, legal proceedings, and from regulators, will be re-assessed to correct the publication record.