In yet another departure from the in-house R&D model, a consortium of pharmaceutical companies has agreed to share historical data from dozens of phase III trials to accelerate the discovery of new cancer therapies.
The Project Data Sphere (PDS) project is an online platform – initially launched with data from pharma companies including AstraZeneca, Bayer, Celgene, Janssen, Pfizer and Sanofi, as well as Memorial Sloan Kettering Cancer Centre in the US – designed to collect cancer research data in a single location.
The initiative launched this year with nine anonymised, patient-level data sets from late-stage oncology trials, with another 25 data sets from 10 additional organisations due to be added soon. Information on trials involving around 3,500 patients is already included and the target is to increase that to 25,000 patients within 12 months.
“The platform allows researchers to combine trials to create larger more helpful data sets, something they have wished for a very long time,” according to Stephen Friend, president of PDS partner company Sage Bionetworks.
Among the pharma companies, Sanofi has contributed three data sets in the area of prostate cancer, which is one of the initial targets of the PDS project. A series of individual projects – known as challenges – will be used to encourage organisations to come forward with data sets.
Chief executive Chris Viehbacher said the PDS will “help define an additional path to accelerate cancer research,” adding that with 8.2 million people dying from cancer every year – and given that the attrition rate for clinical testing of promising compounds as high as 95 per cent – a “paradigm shift” is clearly needed in research.
It is anticipated that the PDS data can be deployed to allow for more efficient research through improved trial design and statistical methodology, reduced duplication and smaller trial sizes, as well as the development of broader data standards.
The data will be made available at no charge, although researchers accessing it will need to be registered with the PDS and be affiliated with life science companies, hospitals and institutions, although applications from independent researchers will also be considered.
Howard Scher, chief of the genitourinary oncology service at Memorial Sloan Kettering Cancer Centre, said the PDS: “will enable the research community to bring to light previously unrecognized insights buried within vast amounts of cancer clinical trial data.”
“The benefits of sharing comparator arm data could lead to a better understanding of disease progression and endpoints, and maximise a patient’s contribution beyond a single trial to the benefit of others,” he added.
The PDS initiative also ties in with the pharma industry’s efforts – pressed by regulators such as the European Medicines Agency – to improve the transparency of clinical trial data.