Sense About Science charity joins fight against bid to prevent transparency of trials

The charity Sense About Science plans to intervene in a legal challenge facing the Health Research Authority (HRA) over its work to promote clinical trial transparency.

Richmond Pharmacology, a contract research organisation that runs clinical trials on behalf of drug companies, launched a judicial review against the HRA in March this year.

The HRA, a UK body established to promote and protect the interests of patients in health research, has been working to make clinical trials more transparent. In September 2013 the body made the registration of a clinical trial a condition of approval to run that trial. From April this year it has asked researchers applying to run a clinical trial to declare that all past trials have been registered, including those approved before September 2013. If the decision in the judicial review goes against the HRA this work could be overturned.

The HRA consulted widely on its proposals and received positive support from the Cochrane Collaboration, the Wellcome Trust, and the Medical Research Council, as well as from the public, patients, and doctors.

Sense About Science is one of the organisations behind the AllTrials campaign, which calls for all past and present trials to be registered and for the full methods and results to be reported. The charity has instructed lawyers and will now write to the HRA and Richmond Pharmacology.

Síle Lane, director of campaigns at Sense About Science, commented, “It is shocking that a company is using court action to try to stop transparency. Hidden and unregistered trials are compromising patient care, and, rightly, causing public outrage. The HRA has really led the way with its proposals to check that clinical trials aren’t kept hidden during the trial approval process.”

She added, “Hundreds of members of the public, patients, researchers, doctors and pharmacists have told the HRA that this is exactly what it should be doing. They want the HRA to help right the injustice done to the thousands of patients who have taken part in clinical trials that have been kept hidden. I find it deplorable that one company is trying to stop that.”

Ben Goldacre, author of Bad Science and Bad Pharma and Wellcome research fellow at the London School of Hygiene and Tropical Medicine, said, “There is a very large global community working to ensure that doctors and patients have all the evidence needed to make informed decisions about which treatments work best.

“We also want the UK to maintain its international reputation for producing high quality, reliable evidence that doctors and researchers can trust. We are reviewing the Richmond case against the HRA very closely and will make a decision about intervening very soon.”

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