The Project Data Sphere Initiative: Accelerating Cancer Research by Sharing Data

Abstract

Background. In this paper, we provide background and context regarding the potential for a new data-sharing platform, the Project Data Sphere (PDS) initiative, funded by financial and inkind contributions from the CEO Roundtable on Cancer, to transform cancer research and improve patient outcomes. Given the relatively modest decline in cancer death rates over the past several years, a new research paradigm is needed to accelerate therapeutic approaches for oncologic diseases. Phase III clinical trials generate large volumes of potentially usable information, often on hundreds of patients, including patients treated with standard of care therapies (i.e., controls). Both nationally and internationally, a variety of stakeholders have pursued data-sharing efforts to make individual patientlevel clinical trial data available to the scientific research community. Potential Benefits and Risks of Data Sharing. For researchers, shared data have the potential to foster a more collaborative environment, to answer research questions in a shorter time frame than traditional randomized control trials, to reduce duplication of effort, and to improve efficiency. For industry participants, use of trial data to answer additional clinical questions could increase research and development efficiency and guide future projects through validation of surrogate end points, development of prognostic or predictive models, selection of patients for phase II trials, stratification in phase III studies, and identification of patient subgroups for development of novel therapies. Data transparency also helps promote a public image of collaboration and altruism among industry participants. For patient participants, data sharing maximizes their contribution to public health and increases access to information that may be used to develop better treatments. Concerns about data-sharing efforts include protection of patient privacy and confidentiality. To alleviate these concerns, data sets are deidentified to maintain anonymity. To address industry concerns about protection of intellectual property and competitiveness, we illustrate several models

Crowdsourcing biomedical research: leveraging communities as innovation engines

“…However, the genesis of a Challenge could also be the emergence of new data repositories, the analysis of which could benefit from the crowdsourcing paradigm 31,32,33 . In all cases, the starting point is the definition of the scientific question that the Challenge aims to answer (FIG.…”

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

“…1–4 The European Medicines Agency has implemented a policy to expand public access to data concerning products it approves, 5,6 the Food and Drug Administration is considering how to expand access to data pooled within a product class, 7 major research sponsors 8–12 and journal editors 13 have begun promoting data sharing, and lawmakers’ interest 14 has resulted in legislation authorizing the National Institutes of Health to require all of its grantees to share data. 15,16 Pharmaceutical industry associations have committed to making data more accessible, 17 and several data platforms are now available.…”

Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

“…In spite of, or perhaps because of the debate, a number of major initiatives have been launched over the past 3-4 years to move the field of data sharing in the clinical research sector forward. Project Data Sphere [23,24], CSDR [21,25], Yale University Open Data Access (YODA) [26], Supporting Open Access for Researchers (SOAR) [27], to name a few. The last three are collections of individual patient data from trials receive from 13, 2, and 1 commercial sponsors, respectively.…”

“…The Cancer Data Access system [CDAS, https:// biometry.nci.nih.gov/cdas/ (28 March 2017, date last accessed)] from NCI is one large effort. While there are also many oncology trials with patient level data listed in the platforms mentioned in the previous paragraph, one platform of particular interest to the oncology community is the Project Data Sphere Initiative which houses individual patient data from control groups of a selection of oncology trials primarily from industry [23,24]. This has been valuable for study design and evaluation of baseline covariates and potential enrichment criteria.…”