title: Involvement of low- and middle-income countries in randomized controlled trial publications in oncology.
abstract: BACKGROUND
  We describe trends in participation by investigators from low- and middle-income countries (LMCs) in publications describing oncology randomized control trials (RCTs) over a decade.
  
  
  METHODS
  We used Medline to identify RCTs published in English from 1998 to 2008 evaluating treatment in lung, breast, colorectal, stomach and liver cancers. Data on author affiliations, authorship roles, trial characteristics, funding and interventions were extracted from each article. Countries were stratified as low-, middle- or high-income using World Bank data. Interventions were categorized as requiring basic, limited, enhanced or maximal resources as per the Breast Health Global Initiative classification. Logistic regression was used to identify factors associated with authorship by investigators from LMCs.
  
  
  RESULTS
  454 publications were identified. Proportion of articles with at least one LMC author increased over time from 20% in 1998 to 29% in 2008 (p = 0.01), but almost all LMC authors were from middle-income countries. Proportion of articles with at least one LMC author was higher among articles that explicitly reported recruitment in at least one LMC vs those that did not (76% vs 13%). Among 87 articles (19%) that involved authors from LMCs, 17% had LMC authors as first or corresponding authors, and 67% evaluated interventions requiring enhanced or maximal resources. Factors associated with LMC authorship included industry funding (OR = 3.54, p = 0.0001), placebo comparator arm (OR = 2.57, p = 0.02) and palliative intent treatment (OR = 4.00, p = 0.0003).
  
  
  CONCLUSIONS
  An increasing number of publications describing oncology RCTs involve authors from LMC countries but primarily in non-leadership roles in industry-funded trials.
authors.affiliation: Department of Neurology, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 2115, USA. jcwong@partners.org.|Department of Neurology, Massachusetts General Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 2115, USA. jcwong@partners.org.
authors.forename: Janice C
authors.initials: JC
authors.lastname: Wong
authors.affiliation: Institute for Clinical Evaluative Sciences, G1 44, 2075 Bayview Avenue, Toronto, Ontario, M4N 3 M5, Canada. kimberly.fernandes@ices.on.ca.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Fernandes
authors.affiliation: Department of Medicine, University of Toronto, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada. shubarna.amin@utoronto.ca.
authors.forename: Shubarna
authors.initials: S
authors.lastname: Amin
authors.affiliation: Department of Medical Oncology, University of Queensland School of Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, 4029, Brisbane, Australia. Zarnie.Lwin@health.qld.gov.au.
authors.forename: Zarnie
authors.initials: Z
authors.lastname: Lwin
authors.affiliation: Institute for Clinical Evaluative Sciences, G1 44, 2075 Bayview Avenue, Toronto, Ontario, M4N 3 M5, Canada. monika.krzyzanowska@uhn.ca.|Department of Medicine, University of Toronto, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada. monika.krzyzanowska@uhn.ca.|Department of Medical Oncology & Hematology, Princess Margaret Cancer Centre, 610 University Avenue, Suite 5-206, Toronto, Ontario, M5G 2 M9, Canada. monika.krzyzanowska@uhn.ca.
authors.forename: Monika K
authors.initials: MK
authors.lastname: Krzyzanowska
mesh_terms: D015706:Bibliometrics; D003906:Developing Countries; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D010506:Periodicals as Topic / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*