Pharmacy — NICE approval

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NICE and data confidentiality

The case continues to be made that all information which NICE uses in its decision-making process, should be made available for public scrutiny. NICE very much endorsed this point and should this be accepted, this will have a significant impact on companies. The chairman of NICE, Professor Michael Rawlins, said publicly that he would definitely like to get rid of the confidentiality barrier. ‘The USA Food and Drug Administration is in the public domain and the kind of stuff submitted to NICE is not really commercially sensitive,’ he said.

Industry-funded clinical trials

With regard to industry data, the British Medical Journal has published an interesting related paper, ‘Survey of public information about ongoing clinical trials funded by industry: evaluation of completeness and accessibility’. The paper reviewed online registers of clinical trials in the US, including industry ones, for information on phase III trials of drugs in development for treating either prostate or colon cancer.

The authors found existing trial registers were unlikely to meet user needs, since many ongoing drug trials were not listed. They suggested that there was a clear need for a comprehensive clinical trials register encompassing all ongoing trials, including industry sponsored trials:

‘Pharmaceutical industry pipeline sources, can be used as sources of information about drugs in clinical trial testing, but these sources often contain non-standardised and incomplete information, making it difficult to search and summarise current testing activities.’