NICE Backs All Trials Campaign
The UK National Institute for Health and Clinical Excellence (NICE) joined the supporters of the All Trials campaign, which calls on responsible bodies to ensure that all trials, past and present, for all treatments, are registered and that the full methods and full results are published.
NICE's chairman, Michael Rawlins, said in a statement, “We strongly believe that all clinical trial data should be made available so that that those with responsibility for developing guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.”
Previously the campaign has been backed by patients involved with NICE (PIN), who are an informal group of patient organizations actively involved in NICE technology appraisals, guideline development groups and the appraisal of interventional procedures.
“As a coalition of more than 80 patient groups, we are committed to ensuring that the best interest of patients is at the heart of every decision the NHS takes. This can only happen if the full information about the efficacy of a treatment is available to those making health care decisions,” read the statement.
All Trials was launched in January by the British Medical Journal, Bad Pharma author Ben Goldacre, the charity Sense About Science, the James Lind Alliance, and Oxford University's Centre for Evidence-Based Medicine. The campaign has received the backing of research councils, leading scientific publishers, and over 37,000 signatories. GlasxoSmithKline is currently the only big pharma company to support All Trials.
The campaign has stated that it wants release of clinical study reports, which describe in detail the methods and results of a trial, both negative and positive, but some of the supporters, for example the British Medical Journal and PLOS, an open access scientific publisher, are calling for making raw data sets available upon reasonable request.
Meanwhile, the ABPI has voiced privacy concerns over publishing patient-level information, and its former Director General told PharmaTimesUK last week that pharma should not have to release raw data sets directly for public scrutiny.
“I have to say that the industry, necessarily and properly, is already subjected to scrutiny through the rules for its submission of data to regulatory agencies such as FDA and the EMA. There is always a case for further independent review, provided the reasons for such reviews are valid and that such analyses are carried out by competent authoritative bodies against agreed protocols and methodology, and, importantly, that the results of their analyses are properly peer reviewed before publication.” he said in an interview.
Jones compared the call for pharma to make raw data publicly available to allowing random travellers to gain access to detailed information about the airline they’ve booked with: “I do not expect that each and every passenger or their family or colleagues should need to have the opportunity to see all the logs of every aeroplane in the fleet, the logs and records of every airport maintenance, re-fuelling staff, de-icing procedure, the medical records of the ground staff, pilots and cabin crew, chefs, etc., to establish my view as to whether it is adequately safe for me to travel.”
“We must rely on the regulators and the process of regulation and if that is ever found to be deficient then clearly it needs to be revised by proper procedures. If we undermine that process then, surely we will be subject to increasing misinformation from often incompetent - or even mendacious - sources with attendant media scares, and especially in the case of our medicines, a loss of confidence by patients in their medicines - a situation that can be deleterious to their health,” he added.
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