Data record for the secondary endpoint analysis of regulatory T cell phenotypes from the 'Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D)'

摘要

Supporting data for the secondary endpoint analysis of regulatory T cell phenotypes from 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: Figure 1, Supplementary Figure 3 and 12 in "Human IL-6RhiTIGIT− CD4+CD127lowCD25+ T cells display potent in vitro suppressive capacity and a distinct Th17 profile" The paper describes the impact of single doses of aldesleukin on 22 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 fw211@cam.ac.uk, 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 participants to be identified, or may prejudice the willingness of participants to join future trials?