The National Institute for Health and Care Excellence has said that it will ask for access to clinical trial data from the European regulatory authorities if pharmaceutical companies fail to supply all the relevant data.
In a new update to its process guide for developing technology appraisal recommendations, NICE has strengthened the chapter on declarations to ensure that medical doctors sign a declaration when they make submissions to the Institute stating that they have identified all clinical trial data.
NICE will only approach the European regulatory authorities if the pharmaceutical company has not provided the necessary clinical data.
The move follows calls for increasing transparency from drugmakers, and comes after Roche was criticised for its handling of data for the pandemic flu drug Tamiflu (oseltamivir). The AllTrials group was set up in the UK on the back of the Tamiflu case to call for all past and present clinical trials to be registered and their full methods and summary results reported. NICE points out that it was an early signatory of the AllTrials.net campaign, which has now been signed by 79,855 people and 507 organisations including the Institute and Patients Involved in NICE (PIN).
The organisation has also outlined plans for earlier meetings with companies so that they can get advice early on and address any potential issues with the methodology or presentation of clinical trial data, to help speed up the appraisal process.
Earlier this month, NICE chairman David Haslam was asked by the House of Commons Health Committee whether pharmaceutical companies should be able to keep their data secret, and he responded that everything should be in the public domain.
“My personal view on this is I can see no reason whatsoever not the 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,” Prof Haslam told the Committee.
The Association of the British Pharmaceutical Industry (ABPI) said it supported NICE’s decision. It also welcomed the Institute’s recognition of the fact that pharmaceutical companies are the primary source of clinical trial information in the first instance and that companies should have a direct relationship with NICEin this regard.
“We believe that clinical trial results should be posted in publicly-accessible registries/databases and published in the scientific literature in a timely manner,” said Paul Catchpole, the ABPI’s director of value and access.
