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NEWS: NICE to seek greater access to clinical trial data when appraising drugs

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Mark Platt
Member
Posts: 290
NEWS: NICE to seek greater access to clinical trial data when appraising drugs
Posted on: September 12 2014, 10:38 am

I'm posting this as it links to the presentation that we had from the All Trials group earlier this year.

NICE will ask for access to clinical trial data from the European regulatory authorities if pharmaceutical companies fail to supply all the relevant data. The move follows calls for increasing transparency from pharmaceutical companies and comes after Roche was criticised for its handling of data for the pandemic flu drug Tamiflu.

The AllTrials group was set up in the UK on the back of 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 organisations have signed the AllTrials petition including NICE and patients involved in NICE (PIN).

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 which received responses from over 50 external organisations, including a number of pharmaceutical companies and the Association of the British Pharmaceutical Industry.

In the update, NICE has strengthened the chapter in the process guide on declarations to ensure that medical directors must sign a declaration when they make submissions to NICE declaring that they have identified all clinical trial data.

NICE will only approach the European regulatory authorities if the pharmaceutical companies have not provided the necessary clinical data.

See: http://www.nice.org.uk/News/Article/nice-to-seek-greater-access-to-clinical-trial-data-when-appraising-drugs
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Juliet Bosa
Member
Posts: 21
Re: NEWS: NICE to seek greater access to clinical trial data when appraising drugs
Reply #1 on: September 16 2014, 08:43 am

Dr Julie Fox will be talking about new research in HIV  at the Harrison Wing Patient Forum on the 30th September, 2014 St Thomas’ Hospital at the South Wing Theatre. Please bring a friend. Light meal and refreshement will be served.you can contact me juliet.bosa @gstt. nhs .uk

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