Background: The Project Data Sphere® initiative (PDS) is an independent not-for-profit initiative of the Life Sciences Consortium of the CEO Roundtable on Cancer, with the vision to broadly share, integrate, and analyze historical comparator-arm cancer trial data sets from any source (academic, government, industry, etc.) with protocols, CRFs, and data descriptors, freely online at www.projectdatasphere.org. The goal is to accelerate innovation to improve cancer care.

Method: Launched in April 2014, the PDS website provides registered users access to de-identified patient level raw data from the control arms of Phase 3 oncology clinical trials. The simple and free application does not include merit review. Analytics tools from SAS® are made freely available to users. At the time of the launch, there were 4,000 patient lives across 9 datasets from 7 industry and academic data providers.

Results: As of May 2016, the number of datasets had increased from 9 to 56, with nearly 30,000 patient lives across Prostate, Pancreatic, Breast, Colorectal, Lung, and other cancers. The number of registered users increased from 83 at launch to over 1,200. Data sets were accessed over 4,000 times by a user community from 47 countries with backgrounds in: academia (60%), pharma/biotech industry (17%), clinical practice (2%), and a variety of others. PDS launched the Prostate Cancer DREAM Challenge in the summer of 2015 using data from the platform, attracting over 550 participants from 21 countries. As of May 2016, PDS was aware of 10+ publications being prepared or submitted to review based on analyses using the data from PDS, including DREAM Challenge manuscripts. PDS is currently developing the platform to allow data providers to upload both arms of trial data, and including advanced tools to facilitate research across multiple data sets.

Conclusion: PDS provides a model to share clinical trial data from oncology; the rapid growth of the number of users, downloads, and publications demonstrates a viable approach to accelerating research, including exploring innovative ways to analyze the data (e.g. crowdsourcing) without exposing patients to new clinical trials. The addition of active intervention data to existing control arm data on PDS could truly expedite the pace of clinical research and expand the type of research possible with the platform.