NEPTUNE welcomes and encourages investigators within and external to the network to use the observational clinical data, histopathology data, biosamples, and derived data sets from NEPTUNE patients for their own research.
The NEPTUNE Ancillary Studies (AS) Program provides the mechanism for sharing NEPTUNE data and materials. This program is at the heart of the NEPTUNE mission as we consider NEPTUNE's lasting impact on advancing the science of glomerular disease contingent on its ability to share its resources. More detail on NEPTUNE resources that can be leveraged for studies is available under research overview.
NEPTUNE maintains a well-functioning administrative structure to facilitate resource sharing with the broader scientific community. The infrastructure is supported by the Data and Coordinating Center and by the Publications and Ancillary Committees that are comprised of network investigators.
There are five main steps (click on the figure to the right to enlarge):
- Applicants first explore the potential of their study concept or hypothesis and the feasibility of addressing this hypothesis with representatives of the Ancillary studies Review Committee (ARC). At this step, applicants may also work with members of the NEPTUNE Data Analysis and Coordinating Center (DACC) to assess availability of data or samples and to establish a budget for the proposed study.
- Ancillary Study Application.
- The Data Analysis and Coordinating Center (DACC) conducts an initial feasibility review for biospecimen requests and participant burden.
- The Ancillary studies Review Committee (ARC) reviews the proposal and either: a) recommends to the SC approval or b) requests additional information from the applicant. The ARC meets the first Friday of each month.
- Following ARC approval, the SC reviews and votes for final approval.
In addition to the DACC, NEPTUNE provides a number of resources to help with the study design and development, including:
NEPTUNE tranSMART, a web-based platform that provides available clinical, biospecimen, and biomarker data in an organized ontology. TranSMART is a great way to explore patient population characteristics based on clinical and molecular data.
Nephrotic Variant Server, nephVS, a catalogue of genetic variation for NEPTUNE patients developed by Matt Sampson as part of an ancillary study. The first goal for nephVS is to allow any interested person to perform look ups to check to see if any variants of interest exist in the NEPTUNE cohort. The second goal is to encourage other investigators to contribute nephrotic syndrome genetic data to nephvs to build up a large international database of genetic variation in NS.
NEPTUNE working groups, comprised of NEPTUNE investigators who share common interests, provide an outlet to gather feedback on study concepts and methodologies.
It is expected that all projects that employ NEPTUNE resources and materials will utilize these resources with the stewardship required for use of limited participant specimens, will do so in a fashion that does not put undue burden on NEPTUNE subjects or resources, and will contribute in a collaborative manner to these resources for the advancement of the work of others.
All ancillary studies must have sufficient non-NEPTUNE funding to support the goals of the ancillary study including costs for study personnel, labs, administration, shipping, data extraction, statistical analyses, and integration of new data/biomaterials/analyses into the NEPTUNE infrastructure. Applicants may seek support from the NIH or other funding agencies or compete for funding from a the NephCure Kidney International funding program dedicated specifically to funding NEPTUNE-related ancillary studies.