NICE ‘will go straight to regulators for trial data’

The UK’s National Institute for Health and Care Excellence (NICE) has said it will bypass drugmakers who decline to provide access to clinical trial data and take its request directly to the European regulatory authorities.

The announcement indicates the cost-effectiveness watchdog – already a vocal candidate for full data disclosure – is raising the stakes in the ongoing debate about the transparency of clinical trial results.

Earlier this month, NICE chair Professor David Haslam told MPs on the House of Commons Health Select Committee that he could see “no reason whatsoever not to publish all the data” from trials, adding that there is “a moral imperative from the point of view of the patients who’ve been part of the trials that their time [and] effort should not be ignored.”

NICE wants to update its processes for carrying out appraisals of new drugs and has added a clause requiring medical directors to sign a declaration when they make submissions to NICE declaring that they have identified all clinical trial data.

The agency insists it will only approach the European regulatory authorities if the pharmaceutical companies have not provided the necessary data, and is also introducing a framework for dialogue with companies early on in the appraisal process to try to address “any potential issues with the methodology or presentation of clinical trial data.”

NICE has long been an advocate of full disclosure and is one of the signatories to the AllTrials campaign, which was set up in 2013 in the wake of staunch criticism of Roche for holding back data on the pandemic flu drug Tamiflu (oseltamivir).

Earlier this year, Members of the European Parliament voted by a large majority to adopt the Clinical Trials Regulation, which will make it a legal requirement for pharma companies and other researchers to publish full trial data results, although the AllTrials campaign points out that this will only apply to new drugs, not those already being used today.

Meanwhile, transparency campaigners have reportedly been inundating the Prescription Medicines Code of Practice Authority (PMCPA) with anonymous complaints that companies are not following the pharma industry’s self-regulation code of practice in disclosing trial data.

A number of companies have started to go beyond the voluntary code of practice in terms of data disclosure, while the European Medicines Agency (EMA) is also in the process of drawing up a new policy, albeit amid concerns that its earlier strong line on transparency is being watered down.

Johnson & Johnson recently pledged to not only make clinical trial data available for its products, including clinical study reports (CSRs) and de-identified patient-level data, but also appointed Yale University as an independent body to review researchers requests for access. GlaxoSmithKline (GSK) – also a member of the AllTrials – has made a similar commitment.

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