The Life Sciences Consortium of the US-based CEO Roundtable on Cancer has formally launched Project Data Sphere, a new online platform where registered users can share, integrate and analyse historical patient-level, comparator-arm data from Phase III clinical trials in oncology.

The initiative already has nine datasets available, with an additional 25 datasets from 10 providers on the way. The initial datasets came from AstraZeneca, Bayer, Celgene, Janssen Research and Development, Memorial Sloan Kettering Cancer Center, Pfizer and Sanofi US.

Project Data Sphere (PDS) said it was working with these and other organisations, including the Alliance for Clinical Trials in Oncology (sponsored by the National Cancer Institute), Amgen and Quintiles, to source more cancer datasets.

Sanofi, whose chief executive officer (CEO) Christopher Viehbacher is chair of the CEO Roundtable on Cancer, contributed three Phase III comparator-arm datasets from clinical trials for prostate cancer.

The company said it was also looking at trial data in multiple other tumour types for potential submission.

Paradigm shift

“Globally, more than 8.2 million lives are lost to cancer every year,” Viehbacher commented.

“Making a difference demands a paradigm shift. The Project Data Sphere initiative, with its broad-access approach, will help define an additional path to accelerate cancer research.”

Sanofi has been involved in the project since its inception, collaborating with legal and privacy experts, as well as clinicians, commercial institutions and patient representatives, to address historical barriers to data-sharing and build an optimal framework for the initiative.

Project Data Sphere has done so by employing advanced data-security and anonymisation strategies, and by pooling multiple studies associated with the same diagnosis.

Analytic tools

To help researchers realise the full potential of data-sharing, PDS has teamed up with business-intelligence specialist and CEO Roundtable member SAS Institute, which is providing state-of-the-art analytic tools to registered users within Project Data Sphere.

The PDS platform is available to researchers affiliated with life science companies, hospitals and institutions, as well as independent researchers.

Access is subject to an online-application process that includes a data-user agreement as well as a high-level scan for non-compliant activities.

Any organisation with valid data, whether industry or academic, can upload data once they have signed the relevant agreement, and without any cost to data users or providers.

Research challenges

One way in which the PDS initiative will leverage data-sharing is through a series of focused research challenges. The aim is to come up with innovative solutions to challenging questions by drawing on the diverse expertise within the PDS community.

The first of these planned challenges addresses prostate cancer in collaboration with the Prostate Cancer Foundation, non-profit biomedical-research organisation Sage Bionetworks, The Dream Project, academic experts from the University of North Carolina and the companies that have provided de-identified, patient-level data from oncology trials.

Buried insights

Dr Howard Scher, chief of the Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center, said the PDS platform would “enable the research community to bring to light previously unrecognised insights buried within vast amounts of cancer clinical-trial data”.

Sharing comparator-arm data could lead to better understanding of disease progression and endpoints, as well as maximising individual patients’ contribution “beyond a single trial to the benefit of others”, Scher added.

Robert Hugin, CEO Roundtable on Cancer member as well as chairman and chief executive officer of Celgene, said data-sharing had the potential to “accelerate the speed with which clinical trials are conducted, improve the efficiency of trial designs and assist with the development of data standards applicable to all cancer types”.