NICE Will Ask Regulators for Trial Data if Drug Makers Refuse
The UK’s National Institute for Health and Care Excellence (NICE) are ever increasingly becoming frustrated with drug makers who are not publishing clinical trials data. As NICE is responsible for recommending the coverage of medicines have now taken the step of asking European regulators for data if companies refuse.
NICE issues a statement yesterday, the statement called for increased transparency from the pharmaceutical industry. The pharmaceutical industry has often shied away from calls to release clinical trial data over concerns that they may be giving away trade secrets and breaching patient confidentiality.
Some drug makers, however, have recently taken steps to release data and make the information available to researchers. GlaxoSmithKline, in particular, has tried to lead this effort in the wake of a $3 billion settlement with U.S. authorities that was paid, in part, over allegations that some trial data was never disclosed.
“We strongly believe that all clinical trial data should be made available so that those with responsibility for developing guidance and making treatment decisions have all the necessary information in hand to help them do so safety and efficiently,” Carole Longson, the director of the Health Technology Evaluation Center at NICE, says in a statement.
NICE made note of the recent controversy surrounding Roche and its battle with researchers, who have accused the drug maker of of refusing to release data about it’s Tamiflu medication. The researchers who were from the Cochrane Collaboration have subsequently release a study about the treatment which reported that the Tamiflu medication was proven not to reduce the spread of the flu or its complications. Roche have labelled this study as “seriously flawed” and have since agreed to provide greater disclosure over data.
NICE are huge supporters of the AllTrials campaign and have been campaigning for fulll disclosure of data for some time. The AllTrials campaign was created last year for the purpose of pressuring drug makers into releasing greater disclosure. Nearly 80,000 people and 507 organisations have signed the AllTrials petition calling for increased trial data disclosure.
NICE are not alone in seeking greater transparency in the pharmaceutical industry. A recent survey of members of the Royal College of Physicians in the UK, found that 81% agreed that drug makers have a moral duty to make completed data available to; trial participants, the public and scientific community.
“My personal view on this is I can see no reason whatsoever not to publish all the data, and I think there’s a moral imperative from the point of view of the patients who’ve been part of the trials that their time, their effort shouldn’t be ignored,” NICE chair David Haslam told the U.K. House of Commons last week, according to NICE. “I think everything should be in the public domain.”
As part of new guidelines for product reviews, he noted that NICE has strengthened procedures to ensure that medical directors from drug makers sign a declaration when they make submission to the agency and declare they have identified all clinical trial data.
A spokesman for the Association for the British Pharmaceutical Industry stated: “The ABPI supports NICE’s decision to continue to ask companies to submit all relevant individual clinical trial data. It is welcome that NICE have recognized that pharmaceutical companies are the primary source of clinical trial information in the first instance and that companies should have a direct relationship with NICE in this regard. We believe that it is appropriate that NICE should only approach the European regulatory authorities if the pharmaceutical companies are unable to provide the requested information.”
“The ABPI is committed to greater clinical trial transparency: we believe that clinical trial results should be posted in publicly accessible registries/databases and published in the scientific literature in a timely manner… Furthermore the pharmaceutical industry has been, and continues to be, committed to evolving and addressing the issues relating to transparency in clinical research.”
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