Data record for main results of: Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D)
University of Cambridge
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Waldron-Lynch, F. (2016). Data record for main results of: Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D) [Dataset]. https://www.repository.cam.ac.uk/handle/1810/253110
Supporting data for the main results of the Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D)
The study was approved by the Health Research Authority, National Research Ethics Service, UK (13/EE/0020) and is registered at the International Standard Randomised Controlled Trial Number Register (ISRCTN27852285) and at ClinicalTrials.gov (NCT01827735).
Data available is the anonymised individual-participant-level results aggregated to appear as: Figures (10); Tables (2); Supplementary Figures (14); Supplementary Tables (8).
The paper describes the impact of single doses of aldesleukin on 40 participants followed over the course of 2-3 months. While all obvious personal identifiers have been stripped from the individual-participant-level results, in our view it cannot be anonymised sufficiently to be able to put it into the public domain without risk of participant identification.
Therefore, it cannot be hosted by the University of Cambridge research repository, but is instead available on application to the DILT1D Data Access Committee, contacted via firstname.lastname@example.org, and on completion of a Data Access Agreement.
The Data Access Committee consists of: the Chief Investigator; the Senior Trial Statistician; and the independent Trial Chair; with additional independent advice from the University of Cambridge School of Clinical Medicine's Information Governance team.
Applications will be judged on the following criteria: 1. Has the application been submitted by bona fide researchers? 2. Is the application's purpose in line with the original aims of the trial, and the consents given? 3. Does the application run the risk of producing information that may allow individual trial paricipants to be identified, or may prejudice the willingness of participants to join future trials?
Related publication: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4054640/
Publication Reference: https://doi.org/10.1371/journal.pmed.1002139
This work is funded by the JDRF (9-2011-253), the Wellcome Trust (091157), and the National Institute for Health Research (NIHR) Cambridge Biomedical Research Centre. The research leading to these results has received funding from the European Union's 7th Framework Programme (FP7/2007-2013) under grant agreement no. 241447 (NAIMIT). Team staff were supported by an award from the Sir Jules Thorn Charitable Trust (13/JTA), Medical Research Council (G0800860), the Wellcome Trust (089989, the Wellcome Trust (097997/Z/11/Z). The Cambridge Institute for Medical Research (CIMR) is in receipt of a Wellcome Trust Strategic Award (100140). No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of this data.
This record's URL: https://www.repository.cam.ac.uk/handle/1810/253110
University of Cambridge Clinical School Data Transfer Agreement - representative sample uploaded here