Project Data Sphere is a programme launched by the CEO Roundtable on Cancer’s Life Sciences Consortium (LSC) to pool results from Phase III cancer clinical trials across all tumour types.
The platform will fill the need for a single place “where the community can broadly share, integrate and analyze historical patient level, comparator arm data from academic and industry Phase III cancer clinical trials” with oncology researchers, said the organisers.
Gail Stephens, VP, SAS Institute told Outsourcing-Pharma.com her company is providing the platform and infrastructure for collecting and managing the shared data.
“As such, we put programmers and other staff on the creation and maintenance or enhancing of the website. We have IT staff in place to manage the site [in terms of] users and data.”
SAS is also providing analytic software for use by the researchers who visit the data-sharing site, Stephens told us.
Positive and negative studies
Initial data sets have already been provided by AstraZeneca, Bayer, Celgene, Janssen Research and Development, Pfizer, and Sanofi US. Project Data Sphere said it is also working with Amgen and Quintiles to provide additional data.
Charles Hugh-Jones, Chief Medical Officer, Sanofi, is involved in running the project and told Outsourcing-Pharma.com the shared data will come from both positive and negative completed studies, typically around one year after primary publication. He did not comment on whether this would include trials which terminated early, or which were not published elsewhere.
The website is publically available “and the research community is invited to apply for access,” Sanofi’s Hugh-Jones told us.
When Outsourcing-Pharma.com asked whether there are protections in place to prevent visitors “phishing” for specific patient data, the directors replied: “All interested in gaining access to the data will be directed to fill out a user application and agree to the terms specified in the Data User Agreement.”
The project organisers worked with technology and privacy experts to create the framework, and each company is responsible for honoring restrictions on research it shares, including de-identifying the data in accordance with the law, they added.
Celgene’s CEO Robert Hugin, who is also a member of the CEO Roundtable on Cancer, said the Project Data Sphere initiative could accelerate the speed of clinical trials, improve the efficiency of their designs and “assist with the development of data standards applicable to all cancer types.”
The platform “will enable the research community to bring to light previously unrecognized insights buried within vast amounts of cancer clinical trial data,” added the head of the Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center.
“The benefits of sharing comparator arm data could lead to a better understanding of disease progression and endpoints, and maximize a patient’s contribution beyond a single trial to the benefit of others,” said Howard Scher.