title: Effective recruitment of participants to a phase I study using the internet and publicity releases through charities and patient organisations: analysis of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D).
abstract: BACKGROUND
  A barrier to the successful development of new disease treatments is the timely recruitment of participants to experimental medicine studies that are primarily designed to investigate biological mechanisms rather than evaluate clinical efficacy. The aim of this study was to analyse the performance of three recruitment sources and the effect of publicity events during the Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D).
  
  
  METHODS
  The final study outcome, demography, disease duration, residence and the effect of publicity events on the performance of three recruitment sources (clinics, type 1 diabetes (T1D) disease register and the internet) were analysed from a bespoke DILT1D recruitment database. For the internet source, the origin of website hits in relation to publicity events was also evaluated.
  
  
  RESULTS
  A total of 735 potentially eligible participants were approached to identify the final 45 DILT1D participants. A total of 477 (64%) were identified via the disease register, but only 59 (12%) responded to contact. A total of 317 individuals registered with the DILT1D study team. Self-referral via the study website generated 170 (54%) registered individuals and was the most popular and successful source, with 88 (28%) sourced from diabetes clinics and 59 (19%) from the disease register. Of those with known T1D duration (N = 272), the internet and clinics sources identified a larger number (57, 21%) of newly diagnosed T1D (<100 days post-diagnosis) compared to the register (1, 0.4%). The internet extended the geographical reach of the study, enabling both national and international participation. Targeted website posts and promotional events from organisations supporting T1D research and treatment during the trial were essential to the success of the internet recruitment strategy.
  
  
  CONCLUSIONS
  Analysis of the DILT1D study recruitment outcomes illustrates the utility of an active internet recruitment strategy, supported by patient groups and charities, funding agencies and sponsors, in successfully conducting an early phase study in T1D. This recruitment strategy should now be evaluated in late-stage trials to develop treatments for T1D and other diseases.
  
  
  BACKGROUND
  NCT01827735 (registered: 4 April 2013); ISRCTN27852285 (registered: 23 March 2013); DRN767 (registered: 21 January 2013).
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. james.heywood@cimr.cam.ac.uk.
authors.forename: James
authors.initials: J
authors.lastname: Heywood
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. marina.evangelou@cimr.cam.ac.uk.
authors.forename: Marina
authors.initials: M
authors.lastname: Evangelou
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. donna.goymer@cimr.cam.ac.uk.
authors.forename: Donna
authors.initials: D
authors.lastname: Goymer
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. jane.kennet@cimr.cam.ac.uk.
authors.forename: Jane
authors.initials: J
authors.lastname: Kennet
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. katerina.anselmiova@cimr.cam.ac.uk.
authors.forename: Katerina
authors.initials: K
authors.lastname: Anselmiova
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. cc570@medschl.cam.ac.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Guy
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. co334@medschl.cam.ac.uk.
authors.forename: Criona
authors.initials: C
authors.lastname: O'Brien
authors.affiliation: The Cambridge BioResource, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. sarah.nutland@bioresource.nihr.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Nutland
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. judy.brown@cimr.cam.ac.uk.
authors.forename: Judy
authors.initials: J
authors.lastname: Brown
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. neil.walker@cimr.cam.ac.uk.
authors.forename: Neil M
authors.initials: NM
authors.lastname: Walker
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. john.todd@cimr.cam.ac.uk.
authors.forename: John A
authors.initials: JA
authors.lastname: Todd
authors.affiliation: JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, Department of Medical Genetics, NIHR Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Wellcome Trust/MRC Building, Cambridge Biomedical Campus, Cambridge, CB2 0XY, UK. frank.waldron-lynch@cimr.cam.ac.uk.
authors.forename: Frank
authors.initials: F
authors.lastname: Waldron-Lynch
mesh_terms: D000328:Adult; D002608:Charities; D003922:Diabetes Mellitus, Type 1 / Q000276:immunology*; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage*; D020407:Internet; D008297:Male; D018579:Patient Selection; D050378:T-Lymphocytes, Regulatory / Q000187:drug effects*
chemical_list: D007376:Interleukin-2