title: Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays.
abstract: OBJECTIVE
  To investigate the length of time taken to open UK research sites in multicentre clinical trials and to identify reasons for any delays.
  
  
  METHODS
  A case study, recording key milestone dates from the time a site receives ethical approval through to opening to recruitment. Delay reasons were prospectively logged by trial staff at a minimum of fortnightly periods using a coding system.
  
  
  METHODS
  SANADII, a phase IV pragmatic trial, managed by the Clinical Trials Research Centre, Liverpool. The trial seeks to work with over 100 National Health Service (NHS) sites to meet its recruitment target of 1510 patients.
  
  
  METHODS
  The primary outcome was time from Multicentre Regional Ethics Committee (MREC) approval to site opening using survival analysis. Where sites took over a specified time to reach milestones (>3 months from MREC to Site Specific Information (SSI) submission, >30 days from SSI validation to local R&D approval, or >30 days from local Research and Development (R&D) approval to opening to recruitment), the longest continuous delay during that milestone was identified.
  
  
  RESULTS
  The median opening time for participating sites was 9.7 months (IQR 6.2 to Not Reached). SSI submission took 7 months (IQR 4.1-12.3) from ethics approval, R&D approval took 16 days (IQR 5.0-32.0) from SSI validation and site opening took 15 days (IQR 8.5-40.0) following R&D approval. The longest delays before SSI submission resulted from negotiating excess treatment costs, finalising logistics, collecting CVs and ongoing participation discussions.
  
  
  CONCLUSIONS
  While recently imposed targets are reducing the time taken for R&D departments to approve valid applications, the time taken to open UK research sites remains excessive and must be reduced. At present significant public funds are being used inefficiently in order to navigate NHS systems, challenging the resolve of trial teams and the competitiveness of the UK.
authors.affiliation: Clinical Trials Research Centre, University of Liverpool c/o Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
authors.forename: Anna
authors.initials: A
authors.lastname: Kearney
authors.affiliation: Clinical Trials Research Centre, University of Liverpool c/o Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: McKay
authors.affiliation: Clinical Trials Research Centre, University of Liverpool c/o Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Hickey
authors.affiliation: Clinical Trials Research Centre, University of Liverpool c/o Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
authors.forename: Silviya
authors.initials: S
authors.lastname: Balabanova
authors.affiliation: Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
authors.forename: Anthony G
authors.initials: AG
authors.lastname: Marson
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: Carrol
authors.initials: C
authors.lastname: Gamble
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: Paula
authors.initials: P
authors.lastname: Williamson
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration; D002986:Clinical Trials as Topic; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D013997:Time Factors; D006113:United Kingdom
keywords: PUBLIC HEALTH; STATISTICS & RESEARCH METHODS