title: Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey.
abstract: Many medical research projects encounter difficulties. The objective of this study was to assess the self-reported frequency of difficulties encountered by medical researchers while conducting research and to identify factors associated with their occurrence.
  
  
  
  The authors conducted a cross-sectional survey in 2010 among principal investigators of 996 study protocols approved by the Research Ethics Committee in Geneva, Switzerland, between 2001 and 2005. The authors asked principal investigators to rate the level of difficulty (1: none, to 5: very great) encountered across the research process.
  
  
  
  588 questionnaires were sent back (participation rate 59.0 %). 391 (66.5 %) studies were completed at the time of the survey. Investigators reported that the most frequent difficulties were related to patient enrollment (44.3 %), data collection (26.7 %), data analysis and interpretation (21.5 %), collaboration with caregivers (21.0 %), study design (20.4 %), publication in peer-reviewed journal (20.2 %), hiring of competent study personnel (20.2 %), and getting funding (19.2 %). On average, investigators reported 2.8 difficulties per project (SD 2.8, range 0 to 12). In multivariable analysis, the number of difficulties was higher for studies initiated by public sponsors (vs. private), single center studies (vs. multicenter), and studies about treatment, diagnosis or prognosis (i.e., clinical vs. other studies).
  
  
  
  Medical researchers reported substantial logistical difficulties in conducting clinical research.
authors.affiliation: Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland. stephane.cullati@hcuge.ch.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cullati
authors.affiliation: Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
authors.forename: Delphine S
authors.initials: DS
authors.lastname: Courvoisier
authors.affiliation: Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
authors.forename: Angèle
authors.initials: A
authors.lastname: Gayet-Ageron
authors.affiliation: Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.|Division of Anesthesia, Department of Anesthesiology, Pharmacology and Intensive Care, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Guy
authors.initials: G
authors.lastname: Haller
authors.affiliation: Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Olivier
authors.initials: O
authors.lastname: Irion
authors.affiliation: Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.|Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.
authors.forename: Thomas
authors.initials: T
authors.lastname: Agoritsas
authors.affiliation: Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Rudaz
authors.affiliation: Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
authors.forename: Thomas V
authors.initials: TV
authors.lastname: Perneger
mesh_terms: D002986:Clinical Trials as Topic; D003430:Cross-Sectional Studies; D019538:Health Care Surveys; D006801:Humans; D015999:Multivariate Analysis; D018579:Patient Selection; D012307:Risk Factors
keywords: Barriers; Clinical research; Difficulties; Medical researchers; Research protocols; Switzerland