The announcement from Leo Pharma that it will publish results from clinical trials as far back as 1990 has gone down well with transparency campaigners and the Association of the British Pharmaceutical Industry.
The Danish dermatology specialist says that as of January 1 2014, it will gradually post summary results of Leo-sponsored trials on its website. Starting with the most recent, all the studies will be available within the next three years.
Leo added that it will evaluate each request from researchers, healthcare professionals and patient associations to receive access to anonymised patient-level data for approved products dating back to 2000. The company is setting up a review board comprising independent researchers and representatives from patient associations, which will meet four times a year to review the requests.
Scientific and ethical responsibility
Geraldine Murphy, managing director of Leo's UK & Ireland operations, said that "transparency in relation to clinical trials data is a scientific and ethical responsibility that facilitates informed healthcare decisions".
Sense about Science, which set up the high-profile campaign, along with the BMJ, the Cochrane Collaboration and Bad Pharma author Dr Goldacre, applauded the move, noting that a number of other companies "have made great strides towards clinical trial transparency". In February, GlaxoSmithKline joined AllTrials campaign and committed to making clinical study reports (CSRs) from all its trials since 1990 available; it has also set up infrastructure to share individual patient data with researchers who request it.
Roche has also promised to provide access to CSRs on request and,from January 2014, to patient level data after requests have been reviewed by an independent panel.
Dr Goldacre said that the move is "excellent news", adding that Leo's commitment, "and the commitments from a growing number of other companies, stand in sharp contrast to the obfuscating pharmaceutical industry trade bodies who seem to want to keep secrecy as the norm.”
One of those bodies, the ABPI, said it welcomes Leo's stance, saying it is recognition "that access to information in clinical study reports and patient level datasets may provide important opportunities to conduct future research".
The ABPI, which says it has been "actively involved in accelerating the pace of improvements in clinical trial transparency", will undertake monitoring of compliance with the existing transparency requirements of its Code of Practice for medicines approved since 2012.
