The National Cancer Institute (NCI) has created a centralized, controlled-access database, called the NCTN/NCORP Data Archive, for storing and sharing datasets generated from clinical trials of the National Clinical Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). NCI’s goal is to make these datasets available in a timely manner, on appropriate terms and conditions, to researchers who wish to analyze the data in secondary studies to enhance the public health benefit of the original work.
With some exceptions, the NCTN/NCORP Data Archive includes clinical data from:
- Primary publications of phase 3 trials published as of January 1, 2015 and
- Selected non-primary publications of phase 3 trials published as of April 1, 2018
Note: Data are not available immediately upon publication. Data providers must submit data within 6 months of publication, after which data undergo a review period by NCI and, if applicable, by trial pharmaceutical collaborators. Although exact timelines cannot be predicted, inquiries regarding the status of data from a specific trial not yet available in the Archive can be directed to the Archive Inbox (NCINCTNDataArchive@mail.nih.gov).
The NCTN/NCORP Data Archive also includes clinical data from selected publications of phase 3 trials published prior to January 1, 2015. However, the data available for such legacy publications may include only a limited number of the variables that appeared in the publications.
NCTN/NCORP Data Archive contents supplied for each publication include a clinical dataset, a data dictionary, and limited metadata fields. Datasets are patient-level, de-identified, and include values for all variables used in the published analyses (with minor exceptions that, if present, are explained within the data submission). Data can be used to approximate published study findings, but exact reproduction of previous manuscripts may not be possible in some cases (e.g., when data must be modified for de-identification purposes or have undergone further data cleaning).
For selected trials, imaging data are also available via a link to The Cancer Imaging Archive (TCIA; http://www.cancerimagingarchive.net/), NCI's official imaging repository for NCTN Trials. Requestors seeking both clinical and imaging data must submit requests to the NCTN/NCORP Data Archive.
To request data, the following are required:
- An NCTN/NCORP Data Archive user account with an official Entity email address
- A complete online Data Request Form, including:
- A list of up to 5 trials from which data is being requested
- A brief research plan
- A Data Use Agreement (DUA) containing auto-populated request information and properly formatted, legally-binding signatures by the requestor and an Authorized Representative from his/her Entity.
- Note: The Authorized Representative must have an Entity email address and legally-binding signature authority for the requestor’s Entity. Requestors can generally identify an Authorized Representative by contacting their Entity's Technology Transfer, Sponsored Research, or Corporate Contracts office.
Once a request is submitted, it is reviewed by NCI for adherence to legal and administrative requirements. There is no scientific review of data requests. If data are requested from one or more trials conducted under a collaborative agreement, applicable industry collaborators will review and provide comments on the request.
After a request is approved, the data requestor may download the clinical dataset(s) and associated documentation via secure links within the data requestor’s user account on the website. Please note that since requests are made by trial, the data requestor will have access to all data specific to the requested trial(s).