Campaigners for more openness in clinical trial data have doubled down on their opponents, with a promise to produce their own publications of trials they deem ‘invisible’ or ‘abandoned’.
In an article in the BMJ Peter Doshi, of Johns Hopkins University School of Medicine in Baltimore, Maryland, and his colleagues say that they have amassed some 178,000 pages of drug-company research documents. They say they will give pharmaceutical companies time to publish their own studies on unpublished clinical trials or to correct trials they consider misreported. If this does not happen within a year, the team will deem the data fair game for their own analyses and publications.
Campaigners — many under the banner of the All Trials group — have been pushing for more openness in clinical trials. They cite past examples where drug companies have not published results of trials that might harm their commercial interests, or refused to release detailed data sets for third-party researchers to analyse.
Moves in this direction have included the release by the European Medicines Agency (EMA) of more information (although not without some stumbling blocks). It was this EMA programme of document release, as well as the reams of documents that were put into the public domain during litigation in the United States, that has enabled Doshi and colleagues to build their pharma data cache.
Researchers, including some of this team and other groups, have published analyses of such documents before. But the new paper is an attempt to start a movement: “We call on others to join us, to contribute trial documents they have obtained from public sources that need publishing or republishing, and to help us with the writing. We need volunteers to act in place of those who should have but did not make trial reports visible and accessible,” they write.