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, on 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.
2014 has opened with a new report from the UK Parliament’s Public Accounts Committee. This powerful committee examines public spending by the UK government, and last year called for evidence on the role of clinical trial transparency as it related to Tamiflu.
BMJ, along with many other individuals and organisations, gave evidence to that committee, which has been synthesised into a report available on their website with a number of key recommendations:
- The Department should take action to ensure that the full methods and results are available to doctors and researchers for all trials on all uses of all treatments currently being prescribed, and should also ensure that there is clear and frequent audit of how much information is available and how much has been withheld.
- The Department (of Health) and the Medicine and Healthcare products Regulation Agency should ensure, both prospectively and retrospectively, that clinical trials are registered on an appropriate registry and that the full methods and results of all trials should be available for wider independent scrutiny, beyond the work undertaken by regulators during the licensing process.
- The Department and the MHRA should ensure, both prospectively and retrospectively, that clinical trials are registered on an appropriate registry and that the full methods and results of all trials should be available for wider independent scrutiny, beyond the work undertaken by regulators during the licensing process.
At the European level, the European Medicines Agency's ban on sharing data has been temporarily lifted (see Jim Murray's BMJ blog for background). Also, an update to the Directive on Medicinal Products for Human Use has been agreed and will follow the US in requiring registration of all trials, and publication of summary results within one year of the trial’s completion, as reported by The BMJ.
For more background to clinical trial data transparency, 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.
New research from the University of North Carolina have estimated the frequency with which results of large randomised clinical trials registered with ClinicalTrials.gov are not available to the public.. The researchers concluded that around 29% of trials registered on ClinicalTrials.gov are still unpublished five years later.
Elizabeth Loder, associate editor at The BMJ and associate professor of neurology at Harvard Medical School, wrote 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, in Baltimore, 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 requests under the Freedom of Information Act, legal proceedings, and from regulators, will be reassessed to correct the publication record.