Health minister agrees to meet academics to discuss access to clinical trial dataBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7168 (Published 23 October 2012) Cite this as: BMJ 2012;345:e7168
The health minister Norman Lamb has agreed to meet experts to discuss what he referred to as “the really important issue” of access to all data from clinical trials.
He was responding to a question in parliament on Tuesday 23 October from Sarah Wollaston, a GP and the Conservative MP for Totnes.
Wollaston raised the issue of missing data from clinical trials affecting the evidence on which doctors’ practice is based. She wanted to know whether ministers from the Department of Health for England would meet “academics and doctors to make sure all historical and future data is released in the public domain.”
The campaign for access to missing data is supported by, among others, Fiona Godlee, editor in chief of the BMJ; Virginia Barbour, chief editor of PLOS Medicine and chairwoman of the international Committee on Publication Ethics; Clare Gerada, president of the Royal College of General Practitioners; Richard Horton, editor of the Lancet; Iain Chalmers, founder of the Cochrane Library; and Ben Goldacre, author of the book Bad Pharma and Wellcome research fellow in epidemiology at the London School of Hygiene and Tropical Medicine.
They say that the withholding of data is an ongoing problem that has never been adequately dealt with either by legislation or by codes of conduct in the drug industry.
They give the example of the Cochrane Collaboration having repeatedly failed to gain access to full data from trials of oseltamivir performed by Roche, despite the fact that the UK government spent £500m (€615; $800) on stockpiling the drug.
The European Medicines Agency has also for three years withheld information on two weight loss drugs from the Cochrane Collaboration, while the UK National Institute for Health and Clinical Excellence (NICE) is frequently obliged to withhold information on industry trials from doctors and patients.
Despite a law passed by the US government in 2007 requiring that the results of all clinical trials meeting specific criteria be posted on the website clinicalTrials.gov within a year of completion, a study published by the BMJ found that only one in five eligible trials met the deadline.1 2 And no company or researcher has ever been fined for failing to publish study results.
In an article in The Times on 23 October Goldacre wrote, “We need to ensure that all results of all clinical trials—past and future—on all drugs in current use are available to doctors and patients. Without that information, doctors cannot make informed decisions about treatments. Patients are harmed, and money is wasted. Governments cannot continue to ignore this international scandal.”3
Goldacre said that regulators and NICE can’t make all the information they get publicly available because of confidentiality clauses agreed with the industry.
The European Medicines Agency, which regulates drugs for the UK, has made and broken promises about transparency before, Goldacre said. He added that the new draft of the European Union clinical trials directive would not improve transparency and might even make things worse.
But drug companies and regulators were not the only people at fault. Goldacre berated universities for failing to ensure that contracts with drug companies to sponsor trials run by academics leave the researchers free to withhold negative results. He added, “Ethics committees, which give approval for research projects, have failed to insist that researchers publish results and never check whether they have withheld results from previous trials. The royal medical colleges have also failed to act on this issue and failed even to state publicly that withholding trial information is research misconduct.”
Cite this as: BMJ 2012;345:e7168
bmj.com Editorial: Missing clinical trial data (BMJ 2012;344:d8158, doi:10.1136/bmj.d8158)