title: Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013.
abstract: BACKGROUND
  Industry-sponsored clinical trials, in the past performed almost exclusively in more developed countries, now often recruit participants globally. However, recruitment from outside high-income countries may not represent the ultimate target population for the intervention. Clinical trial registries provide an opportunity to quantify and examine the type of clinical research performed in various geographic regions. We sought to characterize industry-sponsored randomized controlled trials conducted in high-income countries and to compare these trials to those performed outside high-income countries.
  
  
  METHODS
  Clinical trial data on all industry-funded randomized controlled trials conducted between 2006 and 2014 were obtained from the registry ClinicalTrials.gov. Trials were classified according to their study sites as conducted in high or non-high income countries, and data on trial characteristics were collected.
  
  
  RESULTS
  Of 22,511 relevant trials, a total of 6,085 (27.0 %) trials included study sites outside a high-income country, and 2,045 (9.1 %) were conducted exclusively outside high-income countries. Of country groups, Central Europe had the greatest number of trials (3,127), followed by Eastern Europe (2,075). The percentage of trials with study sites outside high-income countries remained relatively constant over the study period. Studies with sites outside high-income countries tended to recruit more participants (median enrolled participants 265 vs. 71, P <0.001), to be longer (median study duration 20 vs. 13 months, P <0.05), and to study more advanced phase interventions (Phase 3 or 4 trial 58 % vs. 33 %, P <0.001).
  
  
  CONCLUSIONS
  More than a quarter of industry-sponsored trials include participants from outside high-income countries and this rate remained stable over the 7-year study period. Trials conducted outside high-income countries tend to be larger, have a longer duration, and study later phase interventions compared to studies performed exclusively in high-income countries.
authors.affiliation: Department of Pediatrics, University of British Columbia, 4500 Oak Street, V6H 3V4, Vancouver, BC, Canada. Srinivas.murthy@cw.bc.ca.|Division of Critical Care, BC Children's Hospital, Vancouver, BC, Canada. Srinivas.murthy@cw.bc.ca.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Murthy
authors.affiliation: Center for Biomedical Informatics, Harvard Medical School, Boston, MA, USA. Kenneth.mandl@childrens.harvard.edu.|Children's Hospital Informatics Program, Boston Children's Hospital, 320 Longwood Avenue, 02115-5737, Boston, MA, USA. Kenneth.mandl@childrens.harvard.edu.|Division of Emergency Medicine, Boston Children's Hospital, Boston, MA, USA. Kenneth.mandl@childrens.harvard.edu.|Department of Pediatrics, Harvard Medical School, Boston, MA, USA. Kenneth.mandl@childrens.harvard.edu.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Mandl
authors.affiliation: Children's Hospital Informatics Program, Boston Children's Hospital, 320 Longwood Avenue, 02115-5737, Boston, MA, USA. florence.bourgeois@childrens.harvard.edu.|Division of Emergency Medicine, Boston Children's Hospital, Boston, MA, USA. florence.bourgeois@childrens.harvard.edu.|Department of Pediatrics, Harvard Medical School, Boston, MA, USA. florence.bourgeois@childrens.harvard.edu.
authors.forename: Florence T
authors.initials: FT
authors.lastname: Bourgeois
mesh_terms: D035843:Biomedical Research; D003906:Developing Countries; D004345:Drug Industry / Q000379:methods*; D005060:Europe; D006801:Humans; D007182:Income; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D035842:Research Subjects; D012109:Research Support as Topic