NICE to seek greater access to clinical trial data when appraising drugs
NICE will ask for access to clinical trial data from European regulatory authorities if pharmaceutical companies fail to supply all relevant data. The move follows calls for increasing transparency from pharma companies and comes after Roche was criticized for its handling of data for the pandemic flu drug Tamiflu.
The AllTrials group was established in the U.K. following the Tamiflu revelations to call for all past and present clinical trials to be registered and their full methods and summary results reported. To date, 79,855 people and 507 organizations have signed the AllTrials petition, including NICE and patients involved in NICE.
NICE has outlined its drive for greater access to trial data in an update to the process guide used for developing technology appraisal recommendations. This follows a public consultation that received responses from over 50 external organizations, including a number of pharma companies and the Association of the British Pharmaceutical Industry (ABPI).
In the update, NICE has strengthened the chapter in the process guide on declarations to ensure medical directors must sign a declaration when they make submissions to NICE declaring they have identified all clinical trial data.
NICE will approach the European regulatory authorities only if the pharma companies have not provided the necessary clinical data.
Elsewhere, NICE has outlined plans for earlier decision problem meetings so companies 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.
Professor Carole Longson, director for the Health Technology Evaluation Center at NICE, said, “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 to hand to help them do so safely and efficiently. Our technology appraisals process guide has been strengthened to ensure that NICE gets all the relevant clinical trial data needed to develop our recommendations.”
At the House of Commons Health Select Committee on NICE last week, NICE chair professor David Haslam was asked whether pharma companies should be able to keep their data secret.
Haslam said, “We were early signatories of the AllTrials.net campaign. We ask for a signature from the U.K. medical director of pharmaceutical companies that we have all the data relevant to the topic—the drug that we’re considering. Again it’s an area we do take extremely seriously.”
“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,” said Haslam. “I think everything should be in the public domain and I’ve always felt that way very strongly.”