Frequently Asked Questions
Frequently Asked Questions
Q: What types of data are being shared?
A: The Project Data Sphere platform is open to historical patient-level data from cancer clinical trials and registries across all tumor types. In addition to the data set, the data provider will share the care report form template, data descriptors, and study protocol.
Q: What are some potential benefits of data sharing?
A: Some potential benefits of data sharing include: a clearer understanding of disease progression and endpoints; more efficient trial designs; development of research standards; and reduced duplication of efforts.
Q: What are some potential benefits of data sharing?
A: Some potential benefits of data sharing include: a clearer understanding of disease progression and endpoints; more efficient trial designs; development of research standards; and reduced duplication of efforts
Q: Is Project Data Sphere involved in oncology research?
A: Project Data Sphere currently supports four ongoing research programs: External Control Arm, Images and Algorithms, Immune-Related Adverse Events, and Rare Tumor Registries. Each has an associated task force chaired by an eminent scientist and whose members draw from FDA, academia and industry. Project Data Sphere has identified the funding for these research programs and functions as a facilitator.
Q: Are there plans to expand Project Data Sphere’s scope beyond oncology?
A: Not at this time.
Q: Who may access the Project Data Sphere database?
A: All interested in gaining access will be directed to fill out a user application and agree to the terms specified in the Online Services User Agreement, which can be found here. Parties whose applications cannot be accepted include individuals on the FDA debarment list and individuals to whom data cannot legally be exported.
Q: Is there a cost to use the Project Data Sphere platform?
A: There is no cost to access the data sharing platform or the data.
Q: How is Project Data Sphere funded?
A: Project Data Sphere’s work is funded through CEO Roundtable on Cancer member dues, grants from private foundations, and in-kind support from stakeholders.
Q: What information is needed for access?
A: Details on what is required when applying for access may be found in the Data Platform section of the website.
Q: Do I have to submit a research proposal to gain access to the data housed within the Project Data Sphere platform?
A: No. Unlike other clinical data sharing initiatives, a research proposal is not required to be submitted or approved in order to gain access to the data or analytics tools available within the Project Data Sphere platform. We believe the ease-of-access provided by Project Data Sphere is a true differentiator in enabling scientists to quickly and efficiently explore their research hypotheses.
Q: What analytics tools are available within the Project Data Sphere platform?
A: Through SAS’ generosity, the following analytical tools are available at no cost to registered Project Data Sphere users for their use within the platform: SAS® Life Sciences Analytics Framework, SAS® Visual Analytics, SAS® Visual Data Mining and Machine Learning and the SAS® Data Mapping Tool.
Q: Where does the patient-level data come from?
A: The patient-level data available to registered users has been provided from industry, academia, and other organizations engaged in clinical research. These organizations provide not only the data itself, but also the research protocol, a data dictionary and an annotated case report form to enable researchers to efficiently conduct their research.
Q: What data standards are in place within the Project Data Sphere platform?
A: Project Data Sphere recommends that data be provided to the platform following the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model format (SDTM) or CDISC Analysis Data Model (ADaM) data standards. For more information, please visit www.CDISC.org.
Q: What legal agreements are in place to govern how data will be shared?
A: All registered users enter into an Online Services User Agreement with Project Data Sphere. Additionally, each data provider enters into a Data Sharing Agreement for each data set provided. These agreements can be found in the Data Platform section of the website.