title: The interaction between equipoise and logistics in clinical trials: A case study.
abstract: BACKGROUND
  Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications.
  
  
  BACKGROUND
  Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards.
  
  
  METHODS
  A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual.
  
  
  CONCLUSIONS
  When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.
authors.affiliation: 1 Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
authors.forename: Meredith G
authors.initials: MG
authors.lastname: Warshaw
authors.affiliation: 1 Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.|2 Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Vincent J
authors.initials: VJ
authors.lastname: Carey
authors.affiliation: 3 Department of Pediatrics, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: McFarland
authors.affiliation: 4 Basic Sciences Program, Division of AIDS, NIAID/NIH/DHHS, Bethesda, MD, USA.
authors.forename: Liza
authors.initials: L
authors.lastname: Dawson
authors.affiliation: 5 ICAP, Mailman School of Public Health and College of Physicians and Surgeons, Columbia University, New York, NY, USA.
authors.forename: Elaine
authors.initials: E
authors.lastname: Abrams
authors.affiliation: 6 Division of Pediatric Infectious Disease, Department of Pediatrics, Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Melvin
authors.affiliation: 7 Wits Reproductive Health and HIV Institute (WRHI), University of the Witwatersrand, Johannesburg, Johannesburg, South Africa.
authors.forename: Lee
authors.initials: L
authors.lastname: Fairlie
authors.affiliation: 8 Kelly Government Solutions, Contractor to DAIDS/NIAID/NIH, Rockville, MD, USA.
authors.forename: Hans
authors.initials: H
authors.lastname: Spiegel
authors.affiliation: 9 Harvard T.H. Chan School of Public Health, Boston, MA, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Jay
authors.affiliation: 10 Division of Pediatric Infectious Diseases, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Allison L
authors.initials: AL
authors.lastname: Agwu
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic; D014943:Global Health; D015658:HIV Infections / Q000628:therapy*; D054625:Healthcare Disparities; D006801:Humans; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D012107:Research Design; D057212:Therapeutic Equipoise; D000074822:Treatment Adherence and Compliance; D035501:Uncertainty
keywords: Equipoise; HIV/AIDS; enrollment; international clinical trials; logistics