Astellas Pharma has added its name to the list of companies who have committed to make clinical trial data available through an independent website.
The website – clinicalstudydatarequest.com – allows researchers to request and gain access to clinical trial data from pharma companies in order to support their own research. Each proposal is reviewed by an independent panel before being approved.
Sef Kurstjens, chief medical officer at Astellas, said: “Transparency in the conduct of clinical trials is an important issue for the scientific and medical community today.
“By making our clinical trial data more widely available, we further its potential to increase understanding of disease and, ultimately, to address the unmet needs of patients around the globe.”
Astellas will provide access to anonymised patient-level data from clinical trials completed after January 2010. This will be applicable for products and indications that have been approved in the US and, or, in the EU.
The website was launched by GlaxoSmithKline as part of its commitment to improve access to clinical trial data in response to fierce criticism of the pharma industry’s stance on transparency.
Several other companies have since signed up to the platform, including Astellas, Bayer, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB and ViiV Healthcare.
In addition to joining this cohort Astellas has revised and expanded its global policy on clinical trial data disclosure, which details the firm’s viewpoint in regards to registration of clinical trials, positing and publication of trial results and scientific community access to trial data.
Despite these commitments, and other similar efforts made by the likes of Johnson & Johnson and Pfizer, the issue of access to trial data remains a thorny one for pharma.
Campaigning by groups such as AllTrials has put pressure on the industry in recent years leading to a new policy from the European Medicines Agency regarding the publishing of clinical trial results