CEO Roundtable on Cancer launches data-sharing initiative to accelerate drug development
The CEO Roundtable on Cancer has launched Project Data Sphere, a new online oncology data-sharing platform using de-identified cancer patient information with the goal of accelerating drug discovery—by developing more efficient clinical trial protocols, epidemiological studies and, ultimately, new cancer therapies.
The independent, not-for-profit initiative was designed to provide a single place where the cancer research community can broadly share, integrate and analyze historical patient-level data using phase III clinical trial comparator arm data from academic and industry participants.
“The Project Sphere platform will enable the research community to bring to light previously unrecognized insights buried within vast amounts of cancer clinical trial data,” said Howard Scher, M.D., chief 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.’’
In making the data sets widely available, the active arm data, which is the pass/fail measure of any new therapeutic compound, is not included in Project Data Sphere.
The initiative is launching with nine data sets, with an additional 25 data sets from 10 data providers coming soon. The first datasets are from Memorial Sloan Kettering Cancer Center, Pfizer, AstraZeneca, Bayer, Celgene, Janssen R&D and Sanofi. Celgene, for example, has contributed a prostate cancer data set and next month plans to make breast and lung cancer data available, followed by a hematology data set.
“Data sharing through initiatives such as the Project Data Sphere initiative has the potential to accelerate the speed with which clinical trials are conducted, improve the efficiency of trial designs and assist with development of data standards applicable to all cancer types,” said Robert J. Hugin, chairman and CEO of Celgene and a member of the CEO Roundtable on Cancer.
Project Data Sphere also is working with the Alliance for Clinical Trials in Oncology, which is sponsored by the National Cancer Institute, and has commitments from Amgen and Quintiles.
Hosting the project’s web site and providing analytical tools for researchers pro bono is SAS Institute, a software and analytics company that has pooled multiple studies associated with one type of cancer.
SAS also will provide the tools to register users within Project Data Sphere. These include researchers affiliated with life science companies, hospitals, academic and medical institutions and independent researchers. Participants will fill out an online application that includes a data-user agreement as well as a high-level scan for non-compliant activities.
The initiative also addresses prior obstacles to clinical trial data sharing and works with leading clinical and privacy experts, as well as clinicians, commercial institutions and patient representatives to build a framework to share data responsibly.
Project Data Sphere will launch a series of focused research challenges designed to draw on the diversity of expertise within the community to develop innovative solutions. The first addresses prostate cancer and is in collaboration with the Prostate Cancer Foundation, Sage Bionetworks, the Dream Project and academic experts from the University of North Carolina. Some of the initial participating companies have provided de-identified patient-level data from phase III clinical trials.
“Making a difference demands a paradigm shift,” said Christopher A. Viehbacher, CEO of Sanofi and chair and CEO of the CEO Roundtable on Cancer, saying globally, more than 8.2 million lives are lost to cancer each year. The initiative “will help define an additional path to accelerate cancer research.”