The Wellcome Trust, one of the world’s largest medical funders, is urging researchers to release more details of their drug tests.
The UK-based charity says it now “encourages” its grant recipients to release trial data while cautioning on the need to respect patient confidentiality. “Researchers are encouraged to explore opportunities to make anonymised patient-level data available where appropriate,” it says.
Nicola Perrin, head of the strategic planning and policy unit at the Wellcome Trust, said her organisation was planning to meet others in the pharmaceutical industry to discuss common rules on the release of data.
The action comes as the science and technology committee of the House of Commons discusses “cherry picking” by pharmaceutical companies in selective release of trial results to favour their products.
In response to demands under Freedom of Information requests from independent researchers, the European Medicines Agency has pledged from the start of next year to release all clinical information on new drugs that it has received as soon as it has ruled on the medicine.
However, its decision is being resisted by some parts of the industry, which deny claims of cherry-picking and are worried about risks to their competitive position. AbbVie and InterMune have both sued the agency to prevent release of their data.
There have been requirements in recent years for all clinical trials to be publicly registered in advance and their findings to be published, but there are calls for the release of detailed patient-level records behind the overall results.
Although companies such as GlaxoSmithKline have agreed to release such “raw” data in response to valid academic requests, some patient groups and medical specialists have expressed concerns that it will be difficult to ensure privacy.
The latest Wellcome move follows its efforts over the past decade under Sir Mark Wolpert, its outgoing director, to increase transparency, notably by ensuring that anyone can have free access to research it has funded. The trust has also recently launched its own free online journal.
The revised document says: “The trust believes that making the outputs of trust-funded research available to the widest possible audience is a fundamental part of its mission. We therefore support unrestricted access to the published outputs of research, and expect researchers to maximise opportunities to make their research findings freely available, including negative results.”