In a Sounding Board article published in the New England Journal of Medicine (NEJM), Project Data Sphere (PDS) stakeholders call on organizations to share cancer clinical trial data with global researchers in a responsible way that will advance cancer research for patient benefit.
“It’s critical that we find ways to break down siloes and allow researchers direct data access to ensure we maximize the impact of decades of clinical research,” said Dr. Monica M. Bertagnolli, group chair, Alliance for Clinical Trials in Oncology at Brigham and Women’s Hospital, and president-elect, American Society of Clinical Oncology, and the article’s first author. “Responsible sharing of data is something we owe all trial participants so that we may learn from and expand the research they have enabled.”
Co-author Dr. Martin J. Murphy, chief executive officer of PDS, commented, “While there is broad agreement on the value of optimizing access to clinical trial data, the lack of infrastructure and consensus on appropriate methods to manage data exchange and ownership have slowed progress. The benefits far outweigh the obstacles. Indeed, recently published research documents that big data analysis yields insights that may have an impact on cancer patient care. This manuscript illuminates the need to advance open-access data-sharing from all sectors that house clinical trial data such as industry, academia and government.”
The Project Data Sphere Cancer Research Platform is an open-access cancer data research platform. A free digital library-data laboratory, this platform was launched April 2014 as an independent initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium. This web-based platform was developed for PDS by SAS.
Using this platform, researchers can download, share, integrate and analyze anonymized patient-level data. Data providers—pharmaceutical companies and academic institutions—contribute cancer patient de-identified data. Currently the platform includes 72 datasets derived from almost 42,000 patient lives. Cancer researchers may easily access the site, provided they register and agree to responsible use attestation. More than 1,500 scientists are using PDS in their research aided by the freely available SAS advanced analytics within the platform.
The NEJM article was co-authored by Dr. Oliver Sartor, Tulane Medical School; Dr. Bruce A. Chabner, Massachusetts General Hospital Cancer Center; Dr. Mace L. Rothenberg, Pfizer; Dr. Sean Khozin, FDA; Dr. Charles Hugh-Jones, Carmine Research; and Dr. David M. Reese, Amgen.
“The Project Data Sphere Cancer Research Platform has already helped to refine our understanding of cancer’s complexities,” said Dr. Murphy. “It is now time for all holders of clinical trial data to fulfill the intentions of volunteer clinical trial subjects to derive all the knowledge possible from their clinical trial contributions. We seek new data-sharing partners to build a global research resource for cancer patient benefit.”