Europe’s Clinical Data Transparency Rush — Are You for or Against?
By Jacky Law
The days of companies assuming their licensing data can be protected by commercial confidentiality are over. Some companies have seen the writing on the wall. GlaxoSmithKline, for example, took unprecedented action in October 2012 by promising to make raw data from all its trials available to independent researchers. For Gary Evoniuk, director of publication practices at GSK, data access was an issue for a couple of reasons. “One is that people want to be able to go in and try to replicate our analyses,” he says in a new report entitled, Publication Practices for Compliance and Credibility. “But the more important reason is so that researchers can try and learn from our studies. In the future we hope other companies will join the effort and this will facilitate combining data sets between companies to learn more about diseases and treatments. If one could build up these data sets from the hundreds of studies we do every year and multiply that across pharma companies, you could have a very rich database.”
Sanofi’s chief strategy officer, David-Alexandre Gros, agrees that complete openness is the way forward and that companies should learn to be less defensive. He told the recent Financial Times Global Pharmaceutical and Biotechnology Conference that the industry should have nothing to fear from being open about its trial data.
Indeed, even if there is something to fear, the strength of public opinion is such that companies can be forced into forgoing rights to commercial confidentiality. Roche, for example, recently announced talks with the Cochrane Collaboration about setting up an advisory board, with experts from industry and academia, to review the data behind Tamiflu, the subject of one of the stronger campaigns for all studies, past and present, to be opened up to public scrutiny.
Deep divisions within industry were also seen at a workshop convened by the European Medicines Agency in December 2012 to open the way towards clinical data transparency. The European industry association, EFPIA, says it wants data access to be reviewed on a case-by-case basis while those who spearheaded the campaign for the release of Tamiflu data, argue that all data must be open to independent analysis At that meeting the agency’s executive director, Guido Rasi, said, “The EMA is committed to proactive publication of clinical-trial data, once the marketing authorisation period has ended. We are not here to decide if we publish clinical-trial data, but how.”