13th May 2013
The Health Research Authority releases its report on Transparent research today and announces it will lead the way in promoting clinical trial transparency. The report calls for all UK clinical trials to be registered and the results made available and sets out the practical steps needed to achieve this. It contains proposals to:
- Make registration of a clinical trial a condition of ethics approval for the trial from September 2013
- Work with research funders and sponsors to agree guidelines for making results of trials available
- Set up mechanisms to monitor compliance with these guidelines
- Set standards for how people who have participated in research should be informed about study results
- Work with regulators of professions to address the misconduct of withholding results
The Health Research Authority is the NHS organisation set up in 2011 to protect and promote the interests of patients and the public in health research. Its report on Transparent research is available here. http://www.hra.nhs.uk/hra-news-and-announcements/transparent-research/
Ben Goldacre, author of Bad Pharma and co-founder of AllTrials campaign: “We have known for decades that the results of clinical trials are routinely withheld in medicine. This is one of the most important ethical and practical problems facing medicine today. Some have tried to hide from it: the HRA are demonstrating clear leadership, with impressive and solid practical suggestions. I hope that all in medicine will give the HRA their wholehearted support.
Tracey Brown, director of Sense About Science and co-founder of AllTrials campaign: “The HRA’s call today for all clinical trials to be registered and the results reported is a very welcome addition to the clamour of voices that includes the 300 research organisations, regulators, patient groups and professional bodies who have signed up to the AllTrials campaign. Discussions have already started among these groups on the practical steps needed to fulfil the commitments set out at AllTrials. The HRA’s suggestions are very welcome. Now is the time for every organisation that cares about this issue to join the AllTrials campaign and contribute to these discussions.”
Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials campaign: “I welcome the HRAs report. Patients who contribute to clinical science all over the world know that they are helping to increase knowledge relevant to their needs and the needs of hundreds and thousands with similar needs. Failure to report the results of research to which these volunteers have contributed is unethical, unscientific and a waste of precious research resources.”
Dr Carl Heneghan, director of the Centre of Evidence-Based Medicine: “The Health Research Authority remit is to protect and promote the interests of patients. Therefore it is good news the HRA are endorsing the AllTrials campaign, and calling for the enforcement of existing legislation as well as asking for new sanctions for those who do not comply. A recommendation to ensure those who have participated in clinical trials are informed about the results is a step in the right direction, not only for those who have participated, but also for those who may be considering partaking in future clinical trials.”