NICE has confirmed that it has signed the AllTrials campaign, which aims to make all clinical trial data available for public scrutiny.
Rumours were abound last night on the social media channel Twitter that the UK drug pricing watchdog had signed up to the scheme, which is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports to help drive further scientific understanding.
A spokesman for NICE confirmed to PharmaTimes UK news that NICE has now signed up to AllTrials. Sir Michael Rawlins, chair of NICE, told PharmaTimes: “We strongly believe that all clinical trial data should be made available so that that those with responsibility for developing clinical guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.”
Firms for many years have been accused of not releasing full clinical trial data, and are believed to be ‘burying’ negative trials as these could impact the sales potential of their medicines.
Today’s announcement is a big deal given that NICE is a government-associated body and the primary health technology assessor for pharma drugs in England. It is also recognised globally as the best HTA body and this reputation is helped by its offshoot NICE International, which is helping countries around the world set up or refine their HTA processes.
By backing the campaign, AllTrials now has in NICE a highly reputable organisation at the forefront of assessing pharma data saying that the industry must do more to open up its clinical trial data.
Although NICE will not make a decision on a drug’s efficacy – this is up to the European Medicines Agency – it will sift through a drug’s clinical data during its appraisal in order to see whether the efficacy it can deliver is akin to the price a firm is asking. If a firm is withholding data, this can affect NICE’s ability to accurately assess a drug’s QALY, and could mean the NHS is paying too much for some medicines.
The AllTrials campaign is being supported by Bad Pharma author Dr Ben Goldacre and BMJ editor Dr Fiona Godlee. On hearing the new Dr Goldacre tweeted: “Hurrah! About time too!”.
Earlier this month the campaign received a major boost when UK-based firm GlaxoSmithKline became the first pharma company to sign its register.
GSK has so far been the only firm to take this step – the ABPI has said it will not sign up to full public disclosure, citing concerns about patients’ privacy.
AllTrials wants to see the publication of study reports from all clinical trials conducted since the 1990s on treatments currently in use internationally, as well as registration of all clinical trials.