NCTN/NCORP Data Archive: Expanding Access to Clinical Trial Data

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【 This post was originally published on here. 】

February 6, 2017, by Jeff Abrams, M.D., and Warren Kibbe, Ph.D.

Over the past few years, we’ve made great strides in making cancer research data and resources more broadly available and accessible to the cancer research and care community.

Consistent with this trend, today NCI is launching the NCTN/NCORP Data Archive. This new centralized database is a repository of patient-level data from phase III clinical trials conducted by the trials groups that are part of NCI’s National Clinical Trials Network (NCTN), NCI’s Community Oncology Research Program (NCORP), and the National Cancer Institute of Canada-Clinical Trials Group.

The five NCTN groups are leading this effort: the Alliance for Clinical Trials in Oncology, Children’s Oncology Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG.

The NCTN/NCORP Data Archive follows on the heels of several other NCI-led data-sharing initiatives, such as the Genomic Data Commons and Cancer Genomics Cloud Pilots, which are democratizing access to genomic and related data from The Cancer Genome Atlas and other sources. These initiatives broaden researchers’ ability to access, annotate, and analyze these data, allowing investigators to more rapidly and thoroughly explore the molecular machinery of tumors and identify new treatment targets.

The NCTN/NCORP Data Archive expands NCI’s data sharing activities into patient-level clinical trial data. This effort complements NCI’s existing data sharing initiatives that have focused primarily on genetic and genomic data, as well as some limited clinical and imaging data. By making these clinical trial data more broadly available, the archive has the potential to increase the value of the NCTN clinical trials portfolio.  

An individual clinical trial can help determine whether a given therapy is more likely to improve patient survival or produce fewer side effects than another. But by giving the broader research community access to patient-level data from these trials, we believe that we can expand the knowledge gained from them and their impact on patient care.

Getting the Ball Rolling

Initially, the NCTN/NCORP Data Archive will house only data that has been stripped of identifying information from a modest number of NCTN trials that were published on or after January 1, 2015.

Moving forward, the group(s) leading NCTN and NCORP trials will submit de-identified patient-level data to NCI within 6 months of publishing findings from the trial’s primary analysis. After appropriate data-quality reviews at NCI, these data will then be added to the NCTN/NCORP Data Archive.

Warren Kibbe, Ph.D.

Warren Kibbe, Ph.D.
Director, NCI Center for Biomedical Informatics and Information Technology

Credit: National Cancer Institute

Our intention is also for the community to be able to access data from “legacy” NCTN trials—those published before January 1, 2015—although those data will be added to the archive on a case-by-case basis, based on requests for those data and the resources available to complete the requests.

Requests for access to patient-level data from NCTN legacy trials should be sent to NCINCTNDataArchive@mail.nih.gov.

Access to the NCTN/NCORP Data Archive will be controlled; those who want to access the data will have to apply and complete a data use agreement approved by an appropriate authority at their requesting organization or institution (as applicable).

It’s important to stress, however, that the archive was established with the mindset that, when feasible, data from publicly funded research studies should be shared as broadly as possible. So we encourage all those with an interest in analyzing these data sets to investigate this new tool.

Future Steps

The first trials included in the archive will not include those run with biopharmaceutical industry partners. We are working with a number of companies to establish agreements that will allow us to begin including data from NCTN-led trials that involved their therapies. 

Jeffrey S. Abrams, M.D.

Jeffrey S. Abrams, M.D.
Acting Director, NCI Clinical Research, Division of Cancer Treatment and Diagnosis

Credit: National Cancer Institute

In addition to ongoing efforts to add data from further NCTN and NCORP trials, NCI will also continue to explore potential partnerships that can enhance the value of this new resource and make more patient-level data from well-designed and -conducted clinical trials available to the community.

For instance, we have been working with Project Data Sphere—a nonprofit organization launched several years ago by the CEO Roundtable on Cancer—to explore additional ways to make patient-level clinical trial data more broadly available.

Greater sharing of research data underlies much of the thinking behind the Beau Biden Cancer Moonshot(SM) and the initiatives emerging from it. By establishing the NCTN/NCORP Data Archive, NCI is building on and contributing to this momentum.

We believe that the NCTN/NCORP Data Archive will become a valuable resource for researchers and organizations committed to advancing progress against cancer. It will greatly enhance NCI’s critical investments in clinical trials and lead to important progress in patient care.