The pharmaceutical industry has signalled its willingness to open up the vast reservoirs of research data held by its companies this week. But campaigners and researchers pushing for more access to clinical trial data say the moves are little and late.
In a statement released yesterday, two of the world’s leading trade bodies said they would “dramatically increase the amount of information available to researchers, patients, and members of the public”.
Europe’s trade body, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and its north American equivalent the Pharmaceutical Research and Manufacturers of America (PhRMA) said they would make information on trials down to patient level available to researchers. They also pledged to make available the detailed ‘clinical study reports’ which some scientists have been demanding.
Medical research is in a critical period at the moment, with an increasingly vocal group of doctors and scientists demanding greater access to drug company data. These campaigners say that access to these data is vital to prevent the industry burying results that are unfavourable to their products, as has happened in past scandals. Some want drug companies to put all their data on clinical trials into the public domain, while others think researchers should be able to request information from trials that could be released to them after they have been vetted by an independent panel.
This call has been heeded by some bodies, notably the European Medicines Agency, a regulator that is trying to make more information available (see: Drug-company data vaults to be opened). But some businesses have resisted, with two companies suing the agency to prevent release of some of their data.
In response to the move from PhRMA and EFPIA, campaigners accused the industry of not going far enough. Carl Heneghan, director of the Centre for Evidence Based Medicine at the University of Oxford a founder of the AllTrials campaign group pushing for greater openness in clinical trials, said the industry announcement was “clouded in caveats” which could allow a company to refuse a request for information if they thought it was not in their interest to release it.
“In terms of the principles for responsible clinical trial data sharing, outlined by the EFPIA and PhRMA these are to be broadly welcomed,” said Heneghan in a statement. “Yet, there are many details that need to be fleshed out to ensure this is little more than just window dressing.”
But in his own statement, Christopher Viehbacher, president of EFPIA and the CEO of Sanofi, said “Companies routinely publish their clinical research, collaborate with academic researchers, and share clinical trial information on public websites. “By endorsing the Principles, biopharmaceutical companies commit to enhance these efforts.”