The BMJ's open data campaign aims to achieve appropriate and necessary independent scrutiny of data from clinical trials. Working with others, we seek to highlight the problems caused by lack of access to data, and we welcome any suggestions on how to take things further.
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The announcement this week that the BMJ will publish clinical trials only if the researchers have agreed to provide detailed patient level data when requested has been applauded by the drug firm GlaxoSmithKline.
Fiona Godlee, editor in chief of the BMJ, said in an editorial that the journal “will require this commitment for all clinical trials of drugs and devices—whether industry funded or not—from January 2013.”
In response, Patrick Vallance, president of pharmaceuticals research and development at GSK, said: “GSK fully supports the commitment made today by BMJ to drive greater transparency of clinical trial data.(Ver)
EFPIA rejects ‘indiscriminate’ transparencyEurope’s pharma trade body has poured tepid water on the idea of open access to clinical trial data, saying that an‘indiscriminate’ approach may cause ‘significant harm’.
Lack of trial transparency is one of the key accusations that critics such as Ben Goldacre, author of Bad Pharma, routinely level against the industry.
But the European Federation of Pharmaceutical Industries and Associations (EFPIA) believes that what it calls ‘responsible’ transparency is the only sensible way forward.
Richard Bergström, the body’s director general, said: “We recognise that we have a responsibility to show leadership in advancing transparency.”
But he went on: “There is a potential for significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way.”
.../... The doctor and author also suggests there is not enough clarity around company involvement, researcher payment or sponsor interference in trials, and he says that pharma uses data highly selectively.
The worry for pharma is that publishing everything would mean that patients and doctors - and perhaps investors - may draw the wrong conclusions from research that has not hit the mark. (Más)
Ver también:
Ratón de biblioteca: "Bad Pharma" / Ben Goldacre
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