Data-sharing project to help answer critical questions in cancer care
The Life Sciences Consortium of the CEO Roundtable on Cancer recently launched the Project Data Sphere initiative, a platform designed to facilitate the sharing, integration and analysis of data from phase 3 comparator arm cancer trials.
The platform, developed with SAS Institute Inc., is the result of a joint initiative between academic and commercial institutions.
Nine datasets are currently available on the platform’s website from AstraZeneca, Bayer, Celgene, Janssen Research and Development, Memorial Sloan Kettering Cancer Center, Pfizer and Sanofi US. These datasets currently represent nearly 4,000 patients across several cancer types.
Amy P. Abernethy
Twenty-five additional datasets from these and other institutions — including Alliance for Clinical Trials in Oncology, Amgen and Quintiles — are expected to be added soon. The datasets will be related to solid tumors and hematologic malignancies.
“What’s exciting about this initiative is that it is both academic and commercial research communities coming together to help reduce the 8.2 million cancer deaths per year,” Charles Hugh-Jones, MD, chief medical officer of Sanofi, told HemOnc Today. “It is providing broad access to cancer data with integrated analytics, available for the first time together. It is a remarkable opportunity to develop solutions for patients by both institution-based and independent researchers.”
Registered users will have access to the datasets, as well as integrated, analytic software tools that will allow investigators to interpret previous research and conduct new research moving forward.
“As members of the Life Sciences Consortium, we asked ourselves a few years ago, what can we do together that no individual can do by themselves?” Hugh-Jones said. “We felt that data sharing was something that could really move the needle in terms of outcomes with cancer research.”
Fulfilling a need
Several challenges — including patient privacy issues, the competition around data ownership, and the ability to aggregate disparate data — previously inhibited data sharing.
“These data-sharing activities are really groundbreaking, first and foremost because working through those practical barriers requires commitment,” Amy P. Abernethy, MD, PhD, the director of the Duke Center for Learning Health Care Academic Research and spokeswoman for Project Data Sphere, told HemOnc Today. “There has been a clear and consistent message that we need these data in order to be able to inform research, and ultimately patient care.”
Pooling enough data in the same fields will allow researchers to evaluate benchmarks for care in a new way.
“No one dataset does the trick because they aren’t large enough, or they are representative enough. They don’t tell enough of the story,” Abernethy said. “Being able to share this larger — and with time, more integrated — set of information will help researchers answer critical questions for cancer care.”
The initiative aims to add more datasets through research challenges. The first planned challenge will focus on prostate cancer through the joint efforts of the Dream Project, Prostate Cancer Foundation, Sage Bionetworks and researchers from the University of North Carolina.
Multiple datasets in the same fields will provide data on the current state of that particular disease, Abernethy said. For example, researchers might be able to generate a more contemporary estimate of the rate of death at 1 year in castration-resistant prostate cancer and use this benchmark to inform future clinical trials.
Such large bodies of data can also allow researchers to further explore biomarkers for a disease.
“When we start to develop new trials, we can compare results against a background that is accurate and aligned with the current state of affairs,” Abernethy said. “It’s very easy to imagine that, once we hit a critical threshold of similar data types that can be combined, we will be able to answer the same research questions for colorectal cancer, multiple myeloma, melanoma, etc.”
For that reason, data will be added continually to the platform, both through these research challenges and as individual datasets.
“The real power of the platform is going to be derived from an ever-increasing body of data,” Hugh-Jones said. “The potential for this is enormous, and we’re looking forward to building on the existing platform and taking it further.”
Impact on R&D
Sharing such large datasets has the potential to change the way clinical trials are conducted.
“There are many great things you can do with shared data,” Hugh-Jones said. “There are people with a huge variety of skill sets — whether it be in mathematics, life sciences, etc. — who can work together on this platform in the future to build out additional uses of these data that will contribute in the long run to patients.”
Researchers might be able to build disease models, optimize trial design and reduce trial size and duplication using these datasets, Hugh-Jones said.
Shared data has the potential to accelerate drug approval by enabling patient matching for clinical trials and supporting adaptive trial design, Abernethy said. The platform could also be helpful in post-approval monitoring of patients.
Practices, along with data, also can be shared.
“Ultimately, the ability to understand the factors that impede either the conduct of trials or the opportunity to demonstrate effective intervention is going to be essential to making the clinical trial process more efficient,” Abernethy said. “As companies are willing to share with other research groups how they’ve conducted their trials, this is going to be a very unique opportunity that’s beyond just the data opportunity. As we start to share best practices, we can conduct clinical trials much more efficiently.”
Social media tools will be added to the platform in its second phase. That will enable collaboration among researchers, Hugh-Jones said.
“Important things start to happen when you put partnerships like this together,” Abernethy said. “The design features of conducting clinical trials and research and development of new interventions are quickly transferred from one group to another. That’s when more innovation starts to happen.” – by Alexandra Todak
CEO Life Sciences Consortium. Project Data Sphere. Available at: www.projectdatasphere.org. Accessed May 5, 2014.
For more information:
Amy P. Abernethy, MD, PhD, can be reached at Duke University School of Medicine, 2301 Erwin Road, Room 1102, Durham, NC 27710.
Charles Hugh-Jones, MD, can be reached at Sanofi US, 55 Corporate Drive, Bridgewater, NJ 08807.
Disclosure: Abernethy reports no relevant financial disclosures. Hugh-Jones reports employment with Sanofi US.